drugset / Trial / NCT02325713

Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers

NCT02325713

Phase 1 Completed 32 enrolled Merck KGaA, Darmstadt, Germany
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2015-01
Primary completion
2015-01
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Praziquantel Small molecule 20 mg/kg Oral
Subject Praziquantel Small molecule 40 mg/kg Oral
Subject Praziquantel Small molecule 60 mg/kg Oral

Indications

No indication recorded.