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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00930215
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE June 29, 2009
First Posted Date  ICMJE June 30, 2009
Last Update Posted Date September 10, 2009
Study Start Date  ICMJE June 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00930215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
  • 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 ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: D961H
    Oral gelatin capsule
  • Drug: D961H
    Oral HPMC capsule
Study Arms  ICMJE
  • Experimental: D961H 40 mg gelatin capsule
    2 way crossover
    Intervention: Drug: D961H
  • Experimental: D961H 40 mg HPMC capsule
    2 way crossover
    Intervention: Drug: D961H
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2009)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00930215
Other Study ID Numbers  ICMJE D961HC00008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MSD, AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Takenobu Masaoka AstraZeneca
Study Director: Masataka Date AstraZeneca KK
Principal Investigator: Shunji Matsuki Kyushu Clinical Pharmacology Research Clinic
PRS Account AstraZeneca
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP