Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: D961H
- Registration Number
- NCT00930215
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
Inclusion Criteria
- Healthy Japanese
- Classified as homo-EM
- Negative for HIV, Hepatitis B, Hepatitis C and syphilis
Exclusion Criteria
- Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description D961H 40 mg gelatin capsule D961H 2 way crossover D961H 40 mg HPMC capsule D961H 2 way crossover
- Primary Outcome Measures
Name Time Method Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5 PK sample at Day 5 of treatment period 1 and treatment period 2
- Secondary Outcome Measures
Name Time Method Evaluate the PK properties of HPMC capsule of D961H 40 mg following repeated oral doses, by assessment of plasma concentrations, mean residence time, time to maximum plasma concentration and half-life on Day 5 PK sample on Day 5 of treatment period 1 and treatment period 2 Evaluate the safety and tolerability of HPMC capsule of D961H 40 mg by assessment of AEs, clinical lab tests, ECG, vital signs. Pre-entry, Day 5 of treatment period 1 and treatment period 2 and follow up (5-7 days after last dose)
Trial Locations
- Locations (1)
Research Site
🇯🇵Fukuoka, Japan