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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Bioequivalence Study

Treatments: Drug: D961H HPMC capsule 20 mg; Drug: D961H Sachet 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01595425

D961TC00001

Details and patient eligibility

About

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.

Full 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

Enrollment: 71 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

D961H Sachet 20 mg

Experimental group

Description:

2 way crossover

Treatment:

Drug: D961H Sachet 20 mg

D961HHPMC Capsule 20 mg

Experimental group

Description:

2 way crossover

Treatment:

Drug: D961H HPMC capsule 20 mg