NCT02325713

Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oral dispersible tablet of praziquantel (ODT-PZQ)	Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
DRUG	Cysticide	Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
DRUG	ODT-PZQ	Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
DRUG	ODT-PZQ	Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
DRUG	ODT-PZQ	Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
DRUG	Cysticide	Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-01-01
• Completion: 2015-03-01
• First posted: 2014-12-25
• Last updated: 2017-02-23
• Results posted: 2017-02-23

Locations

1 site across 1 country: Germany