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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D961H 40 mg gelatin capsule | Experimental | 2 way crossover |
|
| D961H 40 mg HPMC capsule | Experimental | 2 way crossover |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D961H | Drug | Oral gelatin capsule |
| |
| D961H |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takenobu Masaoka | AstraZeneca | Study Chair |
| Masataka Date | AstraZeneca KK | Study Director |
| Shunji Matsuki | Kyushu Clinical Pharmacology Research Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Japan |
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| Drug |
Oral HPMC capsule |
|
| Pre-entry, Day 5 of treatment period 1 and treatment period 2 and follow up (5-7 days after last dose) |