NCT02501109

Comparative Bioavailability Study of Aripiprazole 10 mg Oral Soluble Film vs Abilify® 10 mg Tablet in Healthy Volunteers

A Single-dose, Randomized, Three-period, Crossover Comparative Bioavailability Study of a Novel Formulation of Aripiprazole 10 mg Oral Soluble Film vs the Marketed Formulation Abilify® 10 mg Tablet in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: CMG Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the rate and extent of absorption of Aripiprazole Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male volunteers

Detailed description

The proposed study is a single centre, bioavailability, open-label, randomized, single-dose, 3-period, 6-sequence, crossover study under fasting conditions. Each volunteer will be given a single dose of the Test formulation in two study periods (with and without water), and a single dose of the Reference formulation (with water) in the other study period.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Aripiprazole	Healthy volunteers will receive Aripiprazole Oral Soluble Fim(OSF) 10mg orally a single of dose within 28 days

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2015-07-17
• Last updated: 2016-03-24