Trial · NCT02325713
Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers
NCT02325713, Phase 1, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2017-02-23
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ConductScience Library. Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers. Trials, record NCT02325713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02325713
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers
- NCT number
- NCT02325713
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Healthy
- Interventions
- Oral dispersible tablet of praziquantel (ODT-PZQ), Cysticide, ODT-PZQ, ODT-PZQ, ODT-PZQ, Cysticide
- First posted
- 2014-12-25
- Last updated
- 2017-02-23
- Results first posted
- 2017-02-23
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) | Pre-dose,0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of L-PZQ. |
| Secondary | Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | |
| Secondary | Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. |
| Secondary | Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | |
| Secondary | AUC From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) Adjusted for the Actual Administered Dose (AUC0-t, Adj) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | |
| Secondary | Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | AUCextra was reported in terms of percentage of AUC0-inf. |
| Secondary | Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method. |
| Secondary | Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | Frel was calculated for Treatment A versus Treatment B only. It was calculated by using AUC0-∞, with treatment A as the Test and treatment B as the Reference. Frel = AUC0-inf (test) / AUC0-inf (reference). |
| Secondary | Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) | Pre-dose,0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | The pharmacokinetic (PK) population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, 'N' (number of participants analyzed) signifies those subjects who were evaluable for this outcome measure. | Hour*nanograms per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. | hours | MEDIAN |
| SECONDARY | Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, n signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively. | hours | GEOMETRIC_MEAN |
| SECONDARY | Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. | hours | MEDIAN |
| SECONDARY | AUC From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) Adjusted for the Actual Administered Dose (AUC0-t, Adj) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, n signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively. | percentage of AUC0-inf | GEOMETRIC_MEAN |
| SECONDARY | Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, n signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively. | 1/h | GEOMETRIC_MEAN |
| SECONDARY | Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. | percent bioavailability | GEOMETRIC_MEAN |
| SECONDARY | Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment | The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, n signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively. | Liter/hour | GEOMETRIC_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group243
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) | Treatment A: 40 mg/kg Test ODT-PZQ After Meal | 1969.6 | Geometric Coefficient of Variation 47.2 | Hour*nanograms per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) | Treatment B: 40 mg/kg Cysticide Tablet After Meal | 2047.9 | Geometric Coefficient of Variation 60.2 | Hour*nanograms per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) | Treatment C1: 20 mg/kg Test ODT-PZQ After Meal | 345.4 | Geometric Coefficient of Variation 69.5 | Hour*nanograms per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) | Treatment C2: 60 mg/kg Test ODT-PZQ After Meal | 4871.3 | Geometric Coefficient of Variation 42.2 | Hour*nanograms per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) | Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal | 924.9 | Geometric Coefficient of Variation 67.7 | Hour*nanograms per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) | Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal | 1537.7 | Geometric Coefficient of Variation 70.6 | Hour*nanograms per milliliter (h*ng/mL) | |
| Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ | Treatment A: 40 mg/kg Test ODT-PZQ After Meal | L-PZQ | 881.3 | Geometric Coefficient of Variation 57.2 | ng/mL |
| Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ | Treatment B: 40 mg/kg Cysticide Tablet After Meal | L-PZQ | 762.6 | Geometric Coefficient of Variation 59.5 | ng/mL |
| Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ | Treatment C1: 20 mg/kg Test ODT-PZQ After Meal | L-PZQ | 154.6 | Geometric Coefficient of Variation 80.4 | ng/mL |
| Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ | Treatment C2: 60 mg/kg Test ODT-PZQ After Meal | L-PZQ | 1548 | Geometric Coefficient of Variation 32.6 | ng/mL |
1 to 10 of 243Source ClinicalTrials.gov
See all 243 results by groupParticipant flow192
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Intervention Period 1 (2 Days) | STARTED | Sequence A-B-C1-D1 | 2 | |
| Intervention Period 1 (2 Days) | STARTED | Sequence A-B-C1-D2 | 2 | |
| Intervention Period 1 (2 Days) | STARTED | Sequence A-B-C2-D1 | 2 | |
| Intervention Period 1 (2 Days) | STARTED | Sequence A-B-C2-D2 | 2 | |
| Intervention Period 1 (2 Days) | STARTED | Sequence A-B-D1-C1 | 2 | |
| Intervention Period 1 (2 Days) | STARTED | Sequence A-B-D2-C1 | 2 | |
| Intervention Period 1 (2 Days) | STARTED | Sequence A-B-D1-C2 | 2 | |
| Intervention Period 1 (2 Days) | STARTED | Sequence A-B-D2-C2 | 2 | |
| Intervention Period 1 (2 Days) | STARTED | Sequence B-A-C1-D1 | 2 | |
| Intervention Period 1 (2 Days) | STARTED | Sequence B-A-C1-D2 | 2 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 participant flowAdverse events54
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 | Nausea | Gastrointestinal disorders | Treatment A: 40 mg/kg Test ODT-PZQ After Meal | 1 | 31 | |
| other | Nausea | Gastrointestinal disorders | Treatment B: 40 mg/kg Cysticide Tablet After Meal | 1 | 32 | |
| other | Nausea | Gastrointestinal disorders | Treatment C1: 20 mg/kg Test ODT-PZQ After Meal | 0 | 15 | |
| other | Nausea | Gastrointestinal disorders | Treatment C2: 60 mg/kg Test ODT-PZQ After Meal | 4 | 15 | |
| other | Nausea | Gastrointestinal disorders | Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal | 0 | 14 | |
| other | Nausea | Gastrointestinal disorders | Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal | 1 | 15 | |
| other | Vomiting | Gastrointestinal disorders | Treatment A: 40 mg/kg Test ODT-PZQ After Meal | 0 | 31 | |
| other | Vomiting | Gastrointestinal disorders | Treatment B: 40 mg/kg Cysticide Tablet After Meal | 1 | 32 | |
| other | Vomiting | Gastrointestinal disorders | Treatment C1: 20 mg/kg Test ODT-PZQ After Meal | 0 | 15 | |
| other | Vomiting | Gastrointestinal disorders | Treatment C2: 60 mg/kg Test ODT-PZQ After Meal | 0 | 15 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment A: 40 mg/kg Test ODT-PZQ After Meal | ||
| Total, all-cause mortality | Treatment B: 40 mg/kg Cysticide Tablet After Meal | ||
| Total, all-cause mortality | Treatment C1: 20 mg/kg Test ODT-PZQ After Meal | ||
| Total, all-cause mortality | Treatment C2: 60 mg/kg Test ODT-PZQ After Meal | ||
| Total, all-cause mortality | Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal | ||
| Total, all-cause mortality | Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal | ||
| Total, other adverse events | Treatment A: 40 mg/kg Test ODT-PZQ After Meal | 5 | 31 |
| Total, other adverse events | Treatment B: 40 mg/kg Cysticide Tablet After Meal | 4 | 32 |
| Total, other adverse events | Treatment C1: 20 mg/kg Test ODT-PZQ After Meal | 1 | 15 |
| Total, other adverse events | Treatment C2: 60 mg/kg Test ODT-PZQ After Meal | 6 | 15 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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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