CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Oral dispersible tablet of praziquantel (ODT-PZQ) +5 moredrug
Likely dose
Oral dispersible tablet of praziquantel (ODT-PZQ) 40 milligramfrom 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/NCT02325713
NCT02325713Phase 1Completed
CompareCT.gov

A Phase I, Open-label, Randomized, Four-period, Crossover, Single Center Trial to Assess the Relative Bioavailability of a Single Oral Dose of the New 150 mg Oral Dispersible Tablet (ODT) Formulation of Praziquantel (PZQ), MSC1028703A, at Different Dose Levels vs the Current Commercial 500 mg Tablet Formulation of PZQ in Healthy Male Volunteers

Merck KGaA, Darmstadt, Germany·interventional·Posted Dec 25, 2014·Updated Feb 23, 2017

In Brief

A Phase 1 clinical trial evaluating Oral dispersible tablet of praziquantel (ODT-PZQ), Cysticide, and 1 other intervention for Healthy. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This is a phase I, open-label, randomized, 4 period, crossover, single-center trial. The purpose of this trial is to assess the relative bio-availability of racemate Oral Dispersible Tablet praziquantel (ODT-PQZ) (MSC1028703A) 150 milligram (mg) versus the current marketed praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 25, 2014
Enrollment StartJan 1, 2015
Primary CompletionJan 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 11.5 years ago

Interventions

Oral dispersible tablet of praziquantel (ODT-PZQ)drug

Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.

Cysticidedrug

Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.

ODT-PZQdrug

Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.

ODT-PZQdrug

Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.

ODT-PZQdrug

Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.

Cysticidedrug

Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.