HealthyPhase 1NCT00930215
Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males
A Phase 1 study testing D961H in people with Healthy, run by AstraZeneca at 1 site in Japan.
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 Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- D961H
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2009to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese
- Classified as homo-EM
- Negative for HIV, Hepatitis B, Hepatitis C and syphilis
Who cannot join
- Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Healthy
- Being tested
- D961H
- Keywords
- Healthy volunteer, Japanese males, homo-EM, Bioequivalence study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D961HDrug
Oral gelatin capsule
D961HDrug
Oral HPMC capsule
| Study group | Role | What they receive |
|---|---|---|
| D961H 40 mg gelatin capsule | Experimental | 2 way crossover Receives: Drug: D961H |
| D961H 40 mg HPMC capsule | Experimental | 2 way crossover Receives: Drug: D961H |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Pre-entry, Day 5 of treatment period 1 and treatment period 2 and follow up (5-7 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Takenobu Masaoka, Study chair, AstraZenecaMasataka Date, Study director, AstraZeneca KKShunji Matsuki, Principal investigator, Kyushu Clinical Pharmacology Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930215
- Sponsor's protocol ID
- D961HC00008
- Status last verified
- Sep 2009
- First submitted
- 29 Jun 2009
- Last updated
- 10 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00930215
- Acronym / sponsor ID
- D961HC00008
- Conditions
- Healthy
- Keywords
- Healthy volunteer, Japanese males, homo-EM, Bioequivalence study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Study completion
- Aug 2009 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D961H 40 mg gelatin capsule | Experimental | Drug: D961H2 way crossover |
| D961H 40 mg HPMC capsule | Experimental | Drug: D961H2 way crossover |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Japanese
- Classified as homo-EM
- Negative for HIV, Hepatitis B, Hepatitis C and syphilis
Key exclusion criteria (2 listed)
- Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D961HOral gelatin capsule | Drug | D961H 40 mg gelatin capsule |
| D961HOral HPMC capsule | Drug | D961H 40 mg HPMC capsule |
Primary outcome
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
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takenobu Masaoka study chair
AstraZeneca
Masataka Date study director
AstraZeneca KK
Shunji Matsuki principal investigator
Kyushu Clinical Pharmacology Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D961H in people with Healthy, run by AstraZeneca at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2009.