Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males

AstraZeneca48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

D961HDRUG

Oral gelatin capsule

D961HDRUG

Oral HPMC capsule

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Fukuoka, Japan

Outcomes

Primary Outcomes

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

Time frame: PK sample at Day 5 of treatment period 1 and treatment period 2

Secondary Outcomes

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

Time frame: 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.

Time frame: Pre-entry, Day 5 of treatment period 1 and treatment period 2 and follow up (5-7 days after last dose)

Data from ClinicalTrials.gov

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