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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00930215
First received: June 29, 2009
Last updated: September 9, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Healthy
Drug: D961H
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: June 2009
Study Completion Date: August 2009
Arms Assigned Interventions
Experimental: D961H 40 mg gelatin capsule
2 way crossover
Drug: D961H
Oral gelatin capsule
Experimental: D961H 40 mg HPMC capsule
2 way crossover
Drug: D961H
Oral HPMC capsule

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930215

Locations
Japan
Research Site
Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Takenobu Masaoka AstraZeneca
Study Director: Masataka Date AstraZeneca KK
Principal Investigator: Shunji Matsuki Kyushu Clinical Pharmacology Research Clinic
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00930215     History of Changes
Other Study ID Numbers: D961HC00008
Study First Received: June 29, 2009
Last Updated: September 9, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Healthy volunteer
Japanese males
homo-EM
Bioequivalence study

ClinicalTrials.gov processed this record on April 17, 2014