Trial · NCT00685685
Fasting Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
NCT00685685, Phase 1, Completed, Mutual Pharmaceutical Company, Inc.; results first posted 2009-12-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fasting Bioavailability Study of Lovastatin Tablets and Mevacor Tablets. Trials, record NCT00685685. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00685685
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fasting Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
- NCT number
- NCT00685685
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 54 participants, actual
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.
- Conditions
- Healthy
- Interventions
- Lovastatin 40 mg tablets, Lovastatin (Mevacor®) 40 mg Tablets
- First posted
- 2008-05-28
- Last updated
- 2010-01-20
- Results first posted
- 2009-12-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration. | The maximum or peak concentration that the drug reaches in the plasma. |
| Primary | Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration. | The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule. |
| Primary | Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration. | The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant. |
Source ClinicalTrials.gov
Outcomes3
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) | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration. | Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons. | ng/mL | MEAN |
| PRIMARY | Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration. | Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons. | ng-hr/mL | MEAN |
| PRIMARY | Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration. | 54 subjects were enrolled and 51 subjects completed the study. Lovastatin plasma concentration data for 48 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 3 subjects. Mevacor® plasma concentration data for 50 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 1 subject. | ng-hr/mL | MEAN |
Source ClinicalTrials.gov
Results by group6
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) | Lovastatin 40 mg Tablets | 1.86 | Standard Deviation 1.05 | ng/mL | |
| Maximum Plasma Concentration (Cmax) | Mevacor® 40 mg Tablets | 1.96 | Standard Deviation 1.02 | ng/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | Lovastatin 40 mg Tablets | 30.64 | Standard Deviation 15.79 | ng-hr/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | Mevacor® 40 mg Tablets | 30.36 | Standard Deviation 17.28 | ng-hr/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | Lovastatin 40 mg Tablets | 34.52 | Standard Deviation 17.50 | ng-hr/mL | |
| Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | Mevacor® 40 mg Tablets | 33.80 | Standard Deviation 18.97 | ng-hr/mL |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets | 27 | |
| First Intervention | STARTED | Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets | 27 | |
| First Intervention | COMPLETED | Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets | 27 | |
| First Intervention | COMPLETED | Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets | 27 | |
| First Intervention | NOT COMPLETED | Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets | 0 | |
| First Intervention | NOT COMPLETED | Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets | 0 | |
| Washout Period of 7 Days | STARTED | Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets | 27 | |
| Washout Period of 7 Days | STARTED | Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets | 27 | |
| Washout Period of 7 Days | COMPLETED | Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets | 25 | |
| Washout Period of 7 Days | COMPLETED | Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets | 26 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events26
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 | loose stools | Gastrointestinal disorders | Lovastatin 40 mg Tablets | 0 | 53 | 0 |
| other | loose stools | Gastrointestinal disorders | Mevacor® 40 mg Tablets | 1 | 52 | 1 |
| other | blood creatine phosphokinase increased | Investigations | Lovastatin 40 mg Tablets | 2 | 53 | 2 |
| other | blood creatine phosphokinase increased | Investigations | Mevacor® 40 mg Tablets | 3 | 52 | 3 |
| other | blood urea increased | Investigations | Lovastatin 40 mg Tablets | 1 | 53 | 1 |
| other | blood urea increased | Investigations | Mevacor® 40 mg Tablets | 1 | 52 | 1 |
| other | heart rate decreased | Investigations | Lovastatin 40 mg Tablets | 1 | 53 | 1 |
| other | heart rate decreased | Investigations | Mevacor® 40 mg Tablets | 0 | 52 | 0 |
| other | neutrophil count decreased | Investigations | Lovastatin 40 mg Tablets | 1 | 53 | 1 |
| other | neutrophil count decreased | Investigations | Mevacor® 40 mg Tablets | 1 | 52 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lovastatin 40 mg Tablets | ||
| Total, all-cause mortality | Mevacor® 40 mg Tablets | ||
| Total, other adverse events | Lovastatin 40 mg Tablets | 10 | 53 |
| Total, other adverse events | Mevacor® 40 mg Tablets | 7 | 52 |
| Total, serious adverse events | Lovastatin 40 mg Tablets | 0 | 53 |
| Total, serious adverse events | Mevacor® 40 mg Tablets | 0 | 52 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lovastatin 40 mg Tablets vs Mevacor® 40 mg Tablets: serious adverse events |
Source Trial comparisons
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00685685
GET https://conductscience.org/api/trials/v1/NCT00685685/events?page=2