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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930215
• Other study ID #: D961HC00008
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2009
• Last updated: September 9, 2009
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		PK sample at Day 5 of treatment period 1 and treatment period 2	No
Secondary	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		PK sample on Day 5 of treatment period 1 and treatment period 2	No
Secondary	Evaluate the safety and tolerability of HPMC capsule of D961H 40 mg by assessment of AEs, clinical lab tests, ECG, vital signs.		Pre-entry, Day 5 of treatment period 1 and treatment period 2 and follow up (5-7 days after last dose)	Yes