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

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”

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

Intervention(s) in this Clinical Trial

• Drug: D961H
  • Oral gelatin capsule
• Drug: D961H
  • Oral HPMC capsule

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: D961H 40 mg gelatin capsule
  • 2 way crossover
• Experimental: D961H 40 mg HPMC capsule
  • 2 way crossover

Primary 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
    Safety Issue?: No

Secondary 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
    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)
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Takenobu Masaoka Study Chair AstraZeneca  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00930215

Study ID Number: D961HC00008

ClinicalTrials.gov Identifier: NCT00930215

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency