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

September 9, 2009 updated by: AstraZeneca

Open Label, Randomized, Single Center, 2-way Crossover Bioequivalence Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule 40 mg D961H After Repeated Oral Administration in Japanese Healthy Male Subjects

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D961H 40 mg gelatin capsule
2 way crossover
Drug: D961H
Oral gelatin capsule
Drug: D961H
Oral HPMC capsule
Experimental: D961H 40 mg HPMC capsule
2 way crossover
Drug: D961H
Oral gelatin capsule
Drug: D961H
Oral HPMC capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
PK sample at Day 5 of treatment period 1 and treatment period 2

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Takenobu Masaoka, AstraZeneca
  • Study Director: Masataka Date, AstraZeneca KK
  • Principal Investigator: Shunji Matsuki, Kyushu Clinical Pharmacology Research Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (Estimate)

June 30, 2009

Study Record Updates

Last Update Posted (Estimate)

September 10, 2009

Last Update Submitted That Met QC Criteria

September 9, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D961HC00008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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