Trial · NCT04318535
Bioequivalence (BE) Study of Test Griseofulvin 500 Milligram (mg) Tablets Versus Reference and Dose Proportionality Study of Test Griseofulvin 250 mg and 500 mg Tablets Under Fed Conditions
NCT04318535, Phase 1, Completed, GlaxoSmithKline; results first posted 2020-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bioequivalence (BE) Study of Test Griseofulvin 500 Milligram (mg) Tablets Versus Reference and Dose Proportionality Study of Test Griseofulvin 250 mg and 500 mg Tablets Under Fed Conditions. Trials, record NCT04318535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04318535
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioequivalence (BE) Study of Test Griseofulvin 500 Milligram (mg) Tablets Versus Reference and Dose Proportionality Study of Test Griseofulvin 250 mg and 500 mg Tablets Under Fed Conditions
- NCT number
- NCT04318535
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Antifungal Agents
- Interventions
- Griseofulvin 500 mg, Griseofulvin 250 mg, Reference Griseofulvin 500 mg
- First posted
- 2020-03-24
- Last updated
- 2020-12-28
- Results first posted
- 2020-12-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) for Griseofulvin | Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each period | Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were measured using standard non-compartmental methods. For Griseofulvin 250 mg (T2), dose-normalized Cmax (observed value multiplied by 2) is reported. Adjusted geometric mean and standard error have been presented for all treatments. Adjusted geometric mean is the antilog (exponential) of the least squares mean of the log-transformed data. Statistical analysis of pharmacokinetic parameters was done using mixed model for evaluation of bioquivalence. Point estimate and 90% confidence interval for the ratio of geometric least square mean of the test Griseofulvin 500 mg (T1) to the reference Griseofulvin 500 mg (R) were calculated for Cmax to assess bioequivalence. |
| Primary | Area Under Plasma Concentration-time Curve (AUC) From Zero Hours to Time of Last Quantifiable Concentration (AUC[0-t]) for Griseofulvin | Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each period | Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were measured using standard non-compartmental methods. For Griseofulvin 250 mg (T2), dose-normalized AUC(0-t) (observed value multiplied by 2) is reported. Adjusted geometric mean and standard error have been presented for all treatments. Adjusted geometric mean is the antilog (exponential) of the least squares mean of the log-transformed data. Statistical analysis of pharmacokinetic parameters was done using mixed model for evaluation of bioquivalence. Point estimate and 90% confidence interval for the ratio of geometric least square mean of the test Griseofulvin 500 mg (T1) to the reference Griseofulvin 500 mg (R) were calculated for AUC(0-t) to assess bioequivalence. |
| Primary | AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) for Griseofulvin | Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each period | Blood samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were measured using standard non-compartmental methods. For Griseofulvin 250 mg (T2), dose-normalized AUC(0-inf) (observed value multiplied by 2) is reported. Adjusted geometric mean and standard error have been presented for all treatments. Adjusted geometric mean is the antilog (exponential) of the least squares mean of the log-transformed data. Statistical analysis of pharmacokinetic parameters was done using mixed model for evaluation of bioquivalence. Point estimate and 90% confidence interval for the ratio of geometric least square mean of the test Griseofulvin 500 mg (T1) to the reference Griseofulvin 500 mg (R) were calculated for AUC(0-inf) to assess bioequivalence. |
| Primary | Dose Proportionality of Griseofulvin Using AUC(0-t) Following a Single Dose | Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each period | Blood samples were collected at indicated time-points for pharmacokinetic analysis. Pharmacokinetic parameters were measured using standard non-compartmental methods. Dose proportionality was assessed using mixed model. Slope and 90% confidence interval for the slope are presented. For Griseofulvin 250 mg (T2), dose-normalized (observed value multiplied by 2) AUC(0-t) was used during calculation of dose proportionality. |
| Primary | Dose Proportionality of Griseofulvin Using Cmax Following a Single Dose | Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each period | Blood samples were collected at indicated time-points for pharmacokinetic analysis. Pharmacokinetic parameters were measured using standard non-compartmental methods. Dose proportionality was assessed using mixed model. Slope and 90% confidence interval for the slope are presented. For Griseofulvin 250 mg (T2), dose-normalized (observed value multiplied by 2) Cmax was used during calculation of dose proportionality. |
| Secondary | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) | Up to Day 22 | An adverse event was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the medicinal product. An SAE was any untoward medical occurrence resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect or any other other important medical event that may jeopardize the participant or may require medical or surgical treatment to prevent one of the other outcomes listed before. |
| Secondary | Number of Participants With Any Abnormality in Vital Signs | Up to Day 22 | Systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate, respiration rate and body temperature were measured in semi-supine position after 5 minutes rest. The clinically acceptable range included; SBP: 85 millimeters of mercury (mmHg) to 160 mmHg; DBP: 45 mmHg to 100 mmHg; pulse rate: 40 beats per minute to 110 beats per minute; respiration rate: 8 breaths per minute to 20 breaths per minute; body temperature: 35.5 degrees Celsius to 37.8 degrees Celsius. Number of participants with any abnormality in vital signs are presented. |
| Secondary | Number of Participants With Any Abnormality in Hematology Parameters | Up to Day 22 | Blood samples were collected at indicated time points for assessment of hematology parameters. The clinically acceptable range included; hemoglobin: 12.3-18.0 grams per deciliter (g/dL) (for male) and 11.0-16.0 g/dL (for female), erythrocyte count: 4.0-7.1\*10\^12 cells per liter (for male) and 3.6-5.6\*10\^12 cells per liter (for female), hematocrit: 0.41-0.50 proportion of red blood cells in blood (Male) and 0.35-0.44 proportion of red blood cells in blood (Female), Mean Corpuscular Volume (MCV): 80-96 femtoliters, Mean Corpuscular Hemoglobin (MCH): 27.5-33.2 picogram , Mean Corpuscular Hemoglobin Concentration (MCHC): 33.4-35.5 g/dL, White Blood Cell (WBC) count: 3960-12100 cells per microliter, platelet count: 135-495\*10\^9 cells per liter, neutrophils: 36-88%, eosinophils: up to 14%, basophils: 0-2%, lymphocytes: 18-44%, monocytes: 2-10% of total cells. Number of participants with any abnormality in hematology parameters are presented. |
| Secondary | Number of Participants With Any Abnormality in Clinical Chemistry Parameters | Up to Day 22 | Blood samples were collected at indicated time points for assessment of clinical chemistry parameters. The clinically acceptable range included; blood urea: Up to 55 milligrams per deciliter (mg/dL), random blood glucose: 63-140 mg/dL, blood urea nitrogen: Up to 25 mg/dL, serum creatinine: 0.6-1.3 mg/dL (Male) and 0.4-1.0 mg/dL (Female), total serum bilirubin: 0.00-1.47 mg/dL, direct serum bilirubin: 0.0-0.3 mg/dL, indirect serum bilirubin: 0.0-1.5 mg/dL, aspartate aminotransferase (AST): Up to 70 units per liter (U/L) (Male) and Up to 50 U/L (Female). Number of participants with any abnormality in clinical chemistry parameters are presented. |
| Secondary | Number of Participants With Any Abnormality in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT) | Days -1, 7, 17 and 22 | Blood samples were collected at indicated time points for assessment of clinical chemistry parameter. The clinically acceptable range for ALT included; Up to 7270 units per liter (U/L) (Male) and Up to 50 U/L (Female). Number of participants with any abnormality in ALT levels are presented. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Plasma Concentration (Cmax) for Griseofulvin | Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each period | Bioequivalence (BE) Analysis Set Population comprised of participants completing at least 2 periods with 500 mg test and 500 mg reference treatments of the study. Only those participants with data available at the specified time points were analyzed. | Nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Area Under Plasma Concentration-time Curve (AUC) From Zero Hours to Time of Last Quantifiable Concentration (AUC[0-t]) for Griseofulvin | Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each period | Bioequivalence (BE) Analysis Set Population. Only those participants with data available at the specified time points were analyzed. | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) for Griseofulvin | Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each period | Bioequivalence (BE) Analysis Set Population. Only those participants with data available at the specified time points were analyzed. | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Dose Proportionality of Griseofulvin Using AUC(0-t) Following a Single Dose | Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each period | Dose Proportionality Analysis Set Population comprised of participants completing at least 2 periods with 500 mg test (T1) and 250 mg test (T2) treatments of the study. Only those participants with data available at the specified time points were analyzed. | Slope of log dose | NUMBER |
| PRIMARY | Dose Proportionality of Griseofulvin Using Cmax Following a Single Dose | Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each period | Dose Proportionality Analysis Set Population comprised of participants completing at least 2 periods with 500 mg test (T1) and 250 mg test (T2) treatments of the study. Only those participants with data available at the specified time points were analyzed. | Slope of log dose | NUMBER |
| SECONDARY | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) | Up to Day 22 | Safety Analysis Set Population comprised of all randomized participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Abnormality in Vital Signs | Up to Day 22 | Safety Analysis Set Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Abnormality in Hematology Parameters | Up to Day 22 | Safety Analysis Set Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Abnormality in Clinical Chemistry Parameters | Up to Day 22 | Safety Analysis Set Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Abnormality in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT) | Days -1, 7, 17 and 22 | Safety Analysis Set Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Plasma Concentration (Cmax) for Griseofulvin | Griseofulvin 500 mg (T1) | 2229 | Standard Error 0.03262 | Nanograms per milliliter | |
| Maximum Plasma Concentration (Cmax) for Griseofulvin | Griseofulvin 250 mg (T2) | 2877 | Standard Error 0.03457 | Nanograms per milliliter | |
| Maximum Plasma Concentration (Cmax) for Griseofulvin | Griseofulvin 500 mg (R) | 1927 | Standard Error 0.03262 | Nanograms per milliliter | |
| Area Under Plasma Concentration-time Curve (AUC) From Zero Hours to Time of Last Quantifiable Concentration (AUC[0-t]) for Griseofulvin | Griseofulvin 500 mg (T1) | 54993 | Standard Error 0.05305 | Hours*nanogram per milliliter | |
| Area Under Plasma Concentration-time Curve (AUC) From Zero Hours to Time of Last Quantifiable Concentration (AUC[0-t]) for Griseofulvin | Griseofulvin 250 mg (T2) | 66788 | Standard Error 0.05560 | Hours*nanogram per milliliter | |
| Area Under Plasma Concentration-time Curve (AUC) From Zero Hours to Time of Last Quantifiable Concentration (AUC[0-t]) for Griseofulvin | Griseofulvin 500 mg (R) | 53274 | Standard Error 0.05305 | Hours*nanogram per milliliter | |
| AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) for Griseofulvin | Griseofulvin 500 mg (T1) | 56746 | Standard Error 0.05460 | Hours*nanogram per milliliter | |
| AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) for Griseofulvin | Griseofulvin 250 mg (T2) | 69564 | Standard Error 0.05630 | Hours*nanogram per milliliter | |
| AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) for Griseofulvin | Griseofulvin 500 mg (R) | 55100 | Standard Error 0.05460 | Hours*nanogram per milliliter | |
| Dose Proportionality of Griseofulvin Using AUC(0-t) Following a Single Dose | Griseofulvin 250 mg to 500 mg | 1.214 | 90% Confidence Interval 1.156 to 1.275 | Slope of log dose |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (Day -1 to Day 5) | STARTED | Griseofulvin 500-T1/Griseofulvin 250-T2/Griseofulvin 500-R | 12 | |
| Treatment Period 1 (Day -1 to Day 5) | STARTED | Griseofulvin 250-T2/Griseofulvin 500-R/Griseofulvin 500-T1 | 12 | |
| Treatment Period 1 (Day -1 to Day 5) | STARTED | Griseofulvin 500-R/Griseofulvin 500-T1/Griseofulvin 250-T2 | 12 | |
| Treatment Period 1 (Day -1 to Day 5) | COMPLETED | Griseofulvin 500-T1/Griseofulvin 250-T2/Griseofulvin 500-R | 12 | |
| Treatment Period 1 (Day -1 to Day 5) | COMPLETED | Griseofulvin 250-T2/Griseofulvin 500-R/Griseofulvin 500-T1 | 12 | |
| Treatment Period 1 (Day -1 to Day 5) | COMPLETED | Griseofulvin 500-R/Griseofulvin 500-T1/Griseofulvin 250-T2 | 12 | |
| Treatment Period 1 (Day -1 to Day 5) | NOT COMPLETED | Griseofulvin 500-T1/Griseofulvin 250-T2/Griseofulvin 500-R | 0 | |
| Treatment Period 1 (Day -1 to Day 5) | NOT COMPLETED | Griseofulvin 250-T2/Griseofulvin 500-R/Griseofulvin 500-T1 | 0 | |
| Treatment Period 1 (Day -1 to Day 5) | NOT COMPLETED | Griseofulvin 500-R/Griseofulvin 500-T1/Griseofulvin 250-T2 | 0 | |
| Period1washout(Atleast 7 Days Post-dose) | STARTED | Griseofulvin 500-T1/Griseofulvin 250-T2/Griseofulvin 500-R | 12 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | White blood cell count decreased | Investigations | Griseofulvin 500 mg (T1) | 0 | 36 | 0 |
| other | White blood cell count decreased | Investigations | Griseofulvin 250 mg (T2) | 0 | 36 | 0 |
| other | White blood cell count decreased | Investigations | Griseofulvin 500 mg (R) | 1 | 36 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Griseofulvin 500 mg (T1) | 0 | 36 |
| Total, all-cause mortality | Griseofulvin 250 mg (T2) | 0 | 36 |
| Total, all-cause mortality | Griseofulvin 500 mg (R) | 0 | 36 |
| Total, other adverse events | Griseofulvin 500 mg (T1) | 0 | 36 |
| Total, other adverse events | Griseofulvin 250 mg (T2) | 0 | 36 |
| Total, other adverse events | Griseofulvin 500 mg (R) | 1 | 36 |
| Total, serious adverse events | Griseofulvin 500 mg (T1) | 0 | 36 |
| Total, serious adverse events | Griseofulvin 250 mg (T2) | 0 | 36 |
| Total, serious adverse events | Griseofulvin 500 mg (R) | 0 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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