Conditions: Healthy
Keywords: ODT-PZQ Bio-availability Praziquantel Cysticide Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 32
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None arm 11: None arm 12: None arm 13: None arm 14: None arm 15: None arm 16: None

Interventions: intervention 1: Oral dispersible tablet of praziquantel (ODT-PZQ) intervention 2: Cysticide intervention 3: ODT-PZQ intervention 4: ODT-PZQ intervention 5: ODT-PZQ intervention 6: Cysticide
Intervention descriptions: intervention 1: Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal. intervention 2: Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal. intervention 3: Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal. intervention 4: Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal. intervention 5: Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal. intervention 6: Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.

Protocol document: