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CompletedNCT00930215Updated Sep 10, 2009

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

A Phase 1 interventional study of D961H and D961H in Healthy, sponsored by AstraZeneca. Completed at 1 site in Japan. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-10.

Sponsored by AstraZeneca · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Healthy

Keywords

  • Healthy volunteer
  • Japanese males
  • homo-EM
  • Bioequivalence study
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,498 studies on the registry; 269 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    D961H 40 mg gelatin capsule

    2 way crossover

    Drug: D961H

  • Experimental
    D961H 40 mg HPMC capsule

    2 way crossover

    Drug: D961H

Interventions

  • DrugD961H

    Oral gelatin capsule

  • DrugD961H

    Oral HPMC capsule

06

What researchers measure

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

    Time frame: PK sample at Day 5 of treatment period 1 and treatment period 2

Secondary outcomes

  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)

07

Study locations

1 site
  • Research Site
    Fukuoka, Japan
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2009 and a completion of Aug 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2009
First posted
Jun 30, 2009
Start
Jun 2009
CompletionActual
Aug 2009
Last update
Sep 10, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00930215
Lead sponsor
AstraZeneca
First posted
Jun 30, 2009
Start date
Jun 2009
Completion
Aug 2009
Last update
Sep 10, 2009

Study contacts

Takenobu Masaoka
study chair · AstraZeneca
Masataka Date
study director · AstraZeneca KK
Shunji Matsuki
principal investigator · Kyushu Clinical Pharmacology Research Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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