NCT01595425

Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.

Detailed description

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Conditions

• Bioequivalence Study

Interventions

Type	Name	Description
DRUG	D961H Sachet 20 mg	Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days.
DRUG	D961H HPMC capsule 20 mg	Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days.

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-05-10
• Last updated: 2012-12-12

Locations

1 site across 1 country: Japan