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

AstraZeneca71 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Bioequivalence Study

Interventions

D961H Sachet 20 mgDRUG

Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days.

D961H HPMC capsule 20 mgDRUG

Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days.

Eligibility

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

Medical Language ↔ Plain English

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

Locations (1)

Research Unit

Fukuoka, Fukuoka, Japan

Outcomes

Primary Outcomes

AUCτ and Cmax,ss of D961H

* 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

Time frame: Day 5

Secondary Outcomes

Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2.

* 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

Time frame: Day 5

Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature.

Time frame: Up to 5 to 7 days after the last dose.

Number of participants with adverse events.

Time frame: Up to 5 to 7 days after the last dose.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.