At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 36 enrolled

Drug / intervention

Cesol (Test) +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04314037

NCT04314037Phase 1Completed

Compare CT.gov

A Phase I, Open-label, Randomized, Four-period, Crossover, Fully Replicated, Reference-scaled, Single Center Study to Assess the Bioequivalence of a Single Oral Dose of 1200 mg of the Coated Cesol Tablet Formulation Versus Comparator Biltricide® in Healthy Male Volunteers

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·interventional·Posted Mar 18, 2020·Updated Aug 13, 2021

In Brief

A Phase 1 clinical trial evaluating Cesol (Test) and Biltricide (Reference) for Healthy. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the bioequivalence (BE) of new coated Cesol tablet (Test) versus Biltricide tablets (Comparator) in healthy male participants. Praziquantel (rac-PZQ) is the active ingredient for Cesol and Biltricide tablets.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy

CountriesGermany

Collaborators--

Timeline

Phase 1CompletedFinished

202120222023202420252026

First PostedMar 2020

Enrollment StartJun 2020

Primary CompletionJul 2020

TodayJul 2026

First PostedMar 18, 2020

Enrollment StartJun 17, 2020

Primary CompletionJul 30, 2020

TodayJul 2, 2026

Enrollment to primary: 1 monthPosted 6.3 years ago

Interventions

Cesol (Test)drug

Participant will receive coated cesol tablet in sequence 1 (Day 1 and Day 15) and in sequence 2 (Day 8 and Day 22). A washout period of 7 days will be maintained between 4 treatment periods.

Biltricide (Reference)drug

Participant will receive biltricide tablet in Sequence 1 (Day 8 and Day 22) and in sequence 2 (Day 1 and Day 15). A washout period of 7 days will be maintained between 4 treatment periods.