Trial · NCT03437447
Praziquantel Bioequivalence Study
NCT03437447, Phase 1, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2019-09-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Praziquantel Bioequivalence Study. Trials, record NCT03437447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03437447
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Praziquantel Bioequivalence Study
- NCT number
- NCT03437447
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 60 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Healthy
- Interventions
- Cisticid, Biltricide
- First posted
- 2018-02-19
- Last updated
- 2019-09-18
- Results first posted
- 2019-09-18
Source ClinicalTrials.gov
Registered outcomes16
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 From Time Zero to Last Measurable Concentration (AUC0-t) of L-Praziquantel (L-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | Area under the plasma concentration-time curve from 0 to the time of the last quantifiable concentration. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of L-Praziquantel (L-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | The maximum observed plasma concentration of L-Praziquantel (L-PZQ). |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | Time of the maximum drug concentration. |
| Secondary | Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | Time prior to the first measurable (non-zero) concentration; calculated as last time point at which the concentration is less than (\<) Lower Limit of Quantification (LLOQ) before the occurrence of the first quantifiable concentration. |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | AUC0-inf is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). |
| Secondary | Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | AUCextra was reported in terms of percentage of AUC0-inf. |
| Secondary | Terminal Elimination Half-Life (t1/2) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. |
| Secondary | Terminal Elimination Rate Constant (Lambda Z) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | Lambda Z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method. |
| Secondary | Apparent Clearance (CL/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | 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. |
| Secondary | Apparent Volume of Distribution During Terminal Phase (Vd/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vd/f after oral dose was influenced by the fraction absorbed. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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 From Time Zero to Last Measurable Concentration (AUC0-t) of L-Praziquantel (L-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | Pharmacokinetic (PK) analysis set included all participants who received all administrations of treatment and have PK parameters for AUC0-t and maximum observed plasma concentration (Cmax) in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | Hour*nanogram per milliliter (h*ng/ml) | MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of L-Praziquantel (L-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | ng/mL | MEAN |
| SECONDARY | Time to Reach Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | hours | MEDIAN |
| SECONDARY | Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | hours | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | PK analysis set: All participants who received all administrations of treatment \& have PK parameters for AUC0-t \& Cmax in all periods without any relevant protocol violations \& factors likely to affect comparability of PK results. Here Number analyzed signifies those participants who were evaluable for this outcome measure for specified category. | h*ng/ml | MEAN |
| SECONDARY | Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | PK analysis set: All participants who received all administrations of treatment \& have PK parameters for AUC0-t \& Cmax in all periods without any relevant protocol violations \& factors likely to affect comparability of PK results. Here Number analyzed signifies those participants who were evaluable for this outcome measure for specified category. | Percentage of AUC0-inf | MEAN |
| SECONDARY | Terminal Elimination Half-Life (t1/2) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | PK analysis set: All participants who received all administrations of treatment \& have PK parameters for AUC0-t \& Cmax in all periods without any relevant protocol violations \& factors likely to affect comparability of PK results. Here Number analyzed signifies those participants who were evaluable for this outcome measure for specified category. | hours | MEAN |
| SECONDARY | Terminal Elimination Rate Constant (Lambda Z) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | PK analysis set included all participants who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results. | Per hour | MEDIAN |
| SECONDARY | Apparent Clearance (CL/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | PK analysis set: All participants who received all administrations of treatment \& have PK parameters for AUC0-t \& Cmax in all periods without any relevant protocol violations \& factors likely to affect comparability of PK results. Here Number analyzed signifies those participants who were evaluable for this outcome measure for specified category. | Milliliter per hour | MEAN |
| SECONDARY | Apparent Volume of Distribution During Terminal Phase (Vd/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose | PK analysis set: All participants who received all administrations of treatment \& have PK parameters for AUC0-t \& Cmax in all periods without any relevant protocol violations \& factors likely to affect comparability of PK results. Here Number analyzed signifies those participants who were evaluable for this outcome measure for specified category. | Milliliter | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group75
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 From Time Zero to Last Measurable Concentration (AUC0-t) of L-Praziquantel (L-PZQ) | Cisticid | 441.53 | Standard Deviation 345.70 | Hour*nanogram per milliliter (h*ng/ml) | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of L-Praziquantel (L-PZQ) | Biltricide First Administration | 547.41 | Standard Deviation 384.82 | Hour*nanogram per milliliter (h*ng/ml) | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of L-Praziquantel (L-PZQ) | Biltricide Second Administration | 460.25 | Standard Deviation 343.37 | Hour*nanogram per milliliter (h*ng/ml) | |
| Maximum Observed Plasma Concentration (Cmax) of L-Praziquantel (L-PZQ) | Cisticid | 310.87 | Standard Deviation 249.02 | ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) of L-Praziquantel (L-PZQ) | Biltricide First Administration | 426.42 | Standard Deviation 324.01 | ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) of L-Praziquantel (L-PZQ) | Biltricide Second Administration | 363.20 | Standard Deviation 333.50 | ng/mL | |
| Time to Reach Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Cisticid | L-PZQ | 2.5 | Full Range 1.5 to 5.5 | hours |
| Time to Reach Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Biltricide First Administration | L-PZQ | 2 | Full Range 1 to 3.5 | hours |
| Time to Reach Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Biltricide Second Administration | L-PZQ | 2.5 | Full Range 1 to 4.5 | hours |
| Time to Reach Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) | Cisticid | Rac-PZQ | 2.5 | Full Range 1.5 to 5.5 | hours |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | First Cisticid, Then Biltricide, Then Biltricide | 20 | |
| Treatment Period 1 | STARTED | First Biltricide, Then Cisticid, Then Biltricide | 20 | |
| Treatment Period 1 | STARTED | First Biltricide, Then Biltricide, Then Cisticid | 20 | |
| Treatment Period 1 | COMPLETED | First Cisticid, Then Biltricide, Then Biltricide | 20 | |
| Treatment Period 1 | COMPLETED | First Biltricide, Then Cisticid, Then Biltricide | 20 | |
| Treatment Period 1 | COMPLETED | First Biltricide, Then Biltricide, Then Cisticid | 19 | |
| Treatment Period 1 | NOT COMPLETED | First Cisticid, Then Biltricide, Then Biltricide | 0 | |
| Treatment Period 1 | NOT COMPLETED | First Biltricide, Then Cisticid, Then Biltricide | 0 | |
| Treatment Period 1 | NOT COMPLETED | First Biltricide, Then Biltricide, Then Cisticid | 1 | |
| Treatment Period 2 | STARTED | First Cisticid, Then Biltricide, Then Biltricide | 20 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events33
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 | Joint injury | Injury, poisoning and procedural complications | Cisticid | 1 | 60 | |
| other | Joint injury | Injury, poisoning and procedural complications | Biltricide First Administration | 0 | 60 | |
| other | Joint injury | Injury, poisoning and procedural complications | Biltricide Second Administration | 0 | 60 | |
| other | Headache | Nervous system disorders | Cisticid | 1 | 60 | |
| other | Headache | Nervous system disorders | Biltricide First Administration | 0 | 60 | |
| other | Headache | Nervous system disorders | Biltricide Second Administration | 1 | 60 | |
| other | Nausea | Gastrointestinal disorders | Cisticid | 0 | 60 | |
| other | Nausea | Gastrointestinal disorders | Biltricide First Administration | 0 | 60 | |
| other | Nausea | Gastrointestinal disorders | Biltricide Second Administration | 2 | 60 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Cisticid | 0 | 60 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cisticid | 0 | 60 |
| Total, all-cause mortality | Biltricide First Administration | 0 | 60 |
| Total, all-cause mortality | Biltricide Second Administration | 0 | 60 |
| Total, other adverse events | Cisticid | 2 | 60 |
| Total, other adverse events | Biltricide First Administration | 5 | 60 |
| Total, other adverse events | Biltricide Second Administration | 6 | 60 |
| Total, serious adverse events | Cisticid | 0 | 60 |
| Total, serious adverse events | Biltricide First Administration | 0 | 60 |
| Total, serious adverse events | Biltricide Second Administration | 0 | 60 |
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.
For software
Read this trial from software.
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