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The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects.
A Phase I, Open label, Randomized, Single center, 2 way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) with a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D961S | Experimental | 2 way crossover |
|
| esomeprazole + buffered acetylsalicylic acid | Experimental | 2 way crossover |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D961S | Drug | Oral gelatine capsule |
| |
| Esomeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCÏ„). | All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics. | Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6 |
| Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss) | All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics. | Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Description of D961S PK profile comparing to esomeprazole and ASA combination in terms of AUC0-t,ss, mean residence time (MRT), time to reach Cmax (tmax,ss) and t1/2,ss of esomeprazole and ASA, and AUCÏ„, Cmax,ss, AUC0-t,ss, MRT, tmax,ss and t1/2,ss of SA | All PK variables and plasma concentrations of esomeprazole, ASA and SA at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study site | Hakata | Fukuoka | Japan |
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| Drug |
Oral HPMC capsule |
|
|
| Buffered acetylsalicylic acid | Drug | Tablet |
|
|
| Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6 |
| Description of Safety and tolerability profile of esomeprazole in combination with ASA in terms of adverse events, clinical laboratory tests, blood pressure, pulse rate and body temperature. | Descriptive statistics will be provided for all safety variables, and the analyses will be performed according to the actual treatment. No formal comparison will be performed. | Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose) |
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| 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 |
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