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

Phase 1

Completed

• Conditions: Bioequivalence Study
• Interventions: Drug: D961H HPMC capsule 20 mg; Drug: D961H Sachet 20 mg

• Registration Number: NCT01595425
• Lead Sponsor: AstraZeneca

Brief 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

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 71

Inclusion Criteria

1. Provision of signed and dated, written informed consent prior to any study specific procedures
2. Japanese healthy male subjects aged 20 to 45 years of age
3. Body Mass Index 19-27 kg/m2 and body weight 50-85 kg
4. Clinically normal findings
5. Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19

Exclusion Criteria

1. Significant clinical illness
2. Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
3. Clinical significant condition which could modify the absorption of the investigational product
4. Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
D961HHPMC Capsule 20 mg	D961H HPMC capsule 20 mg	2 way crossover
D961H Sachet 20 mg	D961H Sachet 20 mg	2 way crossover

Primary Outcome Measures

Name	Time	Method
AUCτ and Cmax,ss of D961H	Day 5	* AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration; * Cmax,ss - maximum concentration at steady state

Secondary Outcome Measures

Name	Time	Method
Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2.	Day 5	* AUC0-t,ss-Area under plasma concentration time curve from zero to time of the last measurable concentration at steady state; * MRT- Mean residence time; * tmax,ss -time of maximum concentration at steady state; * t½ -Terminal half-life
Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature.	Up to 5 to 7 days after the last dose.
Number of participants with adverse events.	Up to 5 to 7 days after the last dose.

Trial Locations

Locations (1)

Research Unit; 🇯🇵 Fukuoka-shi, Fukuoka, Japan