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

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ClinicalTrials.gov Identifier: NCT00930215
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: D961H Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Gelatin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930215


Locations
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Japan
Research Site
Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Chair: Takenobu Masaoka AstraZeneca
Study Director: Masataka Date AstraZeneca KK
Principal Investigator: Shunji Matsuki Kyushu Clinical Pharmacology Research Clinic
More Information
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Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00930215    
Other Study ID Numbers: D961HC00008
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: September 10, 2009
Last Verified: September 2009
Keywords provided by AstraZeneca:
Healthy volunteer
Japanese males
homo-EM
Bioequivalence study