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This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.
A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D961H Sachet 20 mg | Experimental | 2 way crossover |
|
| D961HHPMC Capsule 20 mg | Experimental | 2 way crossover |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D961H Sachet 20 mg | Drug | Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„ and Cmax,ss of D961H |
| Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2. |
| Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masataka Date | AstraZeneca R&D Japan | Study Director |
| Masanari Shiramoto | Hakata Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Unit | Fukuoka | Fukuoka | Japan |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| D961H HPMC capsule 20 mg | Drug | Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days. |
|
|
| Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature. |
| Up to 5 to 7 days after the last dose. |
| Number of participants with adverse events. | Up to 5 to 7 days after the last dose. |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |