Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D961S · 1 trial · 1 indication
All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.
All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.
| Arm | Type | Description |
|---|---|---|
| D961S | EXPERIMENTAL | 2 way crossover |
| esomeprazole + buffered acetylsalicylic acid | EXPERIMENTAL | 2 way crossover |
| Name | Type | Description |
|---|---|---|
| D961S | DRUG | Oral gelatine capsule |
| Esomeprazole | DRUG | Oral HPMC capsule |
| Buffered acetylsalicylic acid | DRUG | Tablet |
Inclusion Criteria: * Healthy Japanese males 20-45 years of age * Classified as homo-EM * Negative for HIV, Hepatitis B, Hepatitis C and syphilis * Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) * Body weight 50-85 kg Exclusion Criteria: * Significant clinical illness from 2 weeks preceding t...
D961S is an investigational small molecule developed by AstraZeneca PLC. It has been studied in a Phase 1 bioequivalence trial in Japanese healthy male subjects. The therapeutic indication for D961S has not been disclosed.
D961S is made by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the developer of the compound.
D961S is in Phase 1 development. It is investigational and has not been approved. One Phase 1 trial has been completed, and no trials are currently active.
D961S has been studied in one clinical trial, NCT01494402, titled a study to assess bioequivalence between D961S and esomeprazole plus buffered acetylsalicylic acid in Japanese healthy male subjects. The trial was Phase 1, completed, enrolled 77 participants, and was conducted in Japan.
NCT01494402 was a controlled, randomized Phase 1 bioequivalence study of D961S in Japanese healthy male volunteers aged 20 years and older. It was not double blind, enrolled 77 participants, and has been completed.