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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
History of Changes
  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:

Drug Information available for: Gelatin
U.S. FDA Resources

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 June 17, 2013