Phase 1
Completed N=60
Praziquantel Bioequivalence Study
Healthy
Source: ClinicalTrials.gov NCT03437447 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of L-Praziquantel (L-PZQ) — 441.53; 547.41; 460.25 Hour*nanogram per milliliter (h*ng/ml)
Summary
The purpose of this trial is to assess the bioequivalence (BE) of new 600 milligram (mg) Cisticid tablet (Test) versus 600 mg Biltricide tablets (Reference) at a dose of 1200 mg in healthy male participants. Praziquantel (PZQ) is the active ingredient for Cisticid and Biltricide tablets.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of L-Praziquantel (L-PZQ) |
441.53; 547.41; 460.25 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of L-Praziquantel (L-PZQ) |
310.87; 426.42; 363.20 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) |
2.5; 2; 2.5; 2.5; 2; 2.5 | — |
| SECONDARY Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) |
1; 1; 1; 0.75; 0.75; 0.75 | — |
| 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) |
468.52; 584.23; 497.89; 2130.19; 2509.42; 2189.25 | — |
| SECONDARY Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) |
5.36; 5.49; 5.74; 2.60; 2.84; 2.57 | — |
| SECONDARY Terminal Elimination Half-Life (t1/2) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) |
1.87; 2.59; 2.32; 2.19; 2.54; 2.18 | — |
| SECONDARY Terminal Elimination Rate Constant (Lambda Z) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) |
0.452927; 0.383267; 0.370854; 0.365639; 0.331359; 0.370806 | — |
| SECONDARY Apparent Clearance (CL/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) |
749261.50; 585260.42; 673193.51; 147268.6; 128110.14; 155851.99 | — |
| SECONDARY Apparent Volume of Distribution During Terminal Phase (Vd/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ) |
1540237.10; 1660474.33; 1800582.47; 430368.23; 385223.26; 431494.33 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Racemate PZQ (Rac-PZQ) |
2071.35; 2421.73; 2131.01 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Racemate PZQ (Rac-PZQ) |
1209.15; 1530.23; 1356.18 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs |
2; 5; 6; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) Findings |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- A male participant must agree to use and to have their female partners willing to use additional non-hormonal contraception (for example, condoms or occlusive cap with spermicide, non-hormonal intra-uterine device [IUD], previous sterilization of participant or his partner, being sexually inactive) from Day of randomization up to final end of treatment (EOT) visit
- Gave written informed consent prior to any trial related procedure
- Have a body weight (BW) of greater than (>) 55.0 kilogram (kg) to less than ( 5 cups of coffee a day or equivalent) or inability to stop consuming caffeine from 48 hours prior to drug administration until discharge from the clinic
- Participant is the Investigator or any Sub-Investigator, research assistant, pharmacist, trial coordinator, other staff or relative thereof directly involved in the conduct of the trial
- Vulnerable participants (for example, persons kept in detention)
- Legal incapacity or limited legal capacity
- Other protocol defined exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03437447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.