Relative Bioavailability Trial of L-Praziquantel in Healthy Volunteers

NCT02271984 ↗

Phase 1 Completed 36 enrolled Merck KGaA, Darmstadt, Germany

RandomizedCrossoverOpen-labelTreatment

Summary

This is a phase I, open-label, randomized, 5 period, crossover, single-center trial. The purpose of this trial is to assess the relative bio-availability of L-praziquantel (L-PZQ \[MSC2499550A\]) oral dispersible tablet (ODT) formulation (150 milligram \[mg\]) versus the current marketed racemate praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male volunteers under fed conditions.

Timeline

Start: 2014-10-31
Primary completion: 2014-12-31
Completion: 2014-12-31

Publications

Bagchus WM, Bezuidenhout D, Harrison-Moench E, Kourany-Lefoll E, Wolna P, Yalkinoglu O. Relative Bioavailability of Orally Dispersible Tablet Formulations of Levo- and Racemic Praziquantel: Two Phase I Studies. Clin Transl Sci. 2019 Jan;12(1):66-76. doi: 10.1111/cts.12601. Epub 2018 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Praziquantel	Small molecule	40 mg/kg	Oral
Subject	arpraziquantel	Small molecule	10 mg/kg	Oral
Subject	arpraziquantel	Small molecule	20 mg/kg	Oral
Subject	arpraziquantel	Small molecule	30 mg/kg	Oral

Indications

No indication recorded.