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

NCT01595425 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2012-12-12

No results posted yet for this study

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.

Conditions

  • Bioequivalence Study

Interventions

DRUG

D961H Sachet 20 mg

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

DRUG

D961H HPMC capsule 20 mg

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

Sponsors & Collaborators

Principal Investigators

  • Masataka Date · AstraZeneca R&D Japan

  • Masanari Shiramoto · Hakata Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01595425 on ClinicalTrials.gov