NCT00930215

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 10, 2009

Status Verified

September 1, 2009

First QC Date

June 29, 2009

Last Update Submit

September 9, 2009

Conditions

Healthy

Keywords

Healthy volunteerJapanese maleshomo-EMBioequivalence study

Outcome Measures

Primary Outcomes (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

    PK sample at Day 5 of treatment period 1 and treatment period 2

Secondary Outcomes (2)

  • 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

  • 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)

Study Arms (2)

D961H 40 mg gelatin capsule

EXPERIMENTAL

2 way crossover

Drug: D961H

D961H 40 mg HPMC capsule

EXPERIMENTAL

2 way crossover

Drug: D961H

Interventions

D961HDRUG

Oral gelatin capsule

D961H 40 mg gelatin capsule

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Japanese
  • Classified as homo-EM
  • Negative for HIV, Hepatitis B, Hepatitis C and syphilis

You may not qualify if:

  • Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
  • Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Fukuoka, Japan

Location

Study Officials

  • Takenobu Masaoka

    AstraZeneca

    STUDY CHAIR

  • Masataka Date

    AstraZeneca KK

    STUDY DIRECTOR

  • Shunji Matsuki

    Kyushu Clinical Pharmacology Research Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2009

First Posted

June 30, 2009

Study Start

June 1, 2009

Study Completion

August 1, 2009

Last Updated

September 10, 2009

Record last verified: 2009-09

Locations

JP(1)