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 being studied in a bioequivalence study. It was evaluated in a Phase 1 clinical trial to assess its bioequivalence compared with esomeprazole/buffered acetylsalicylic acid (ASA) in Japanese healthy male subjects. The drug is not approved and remains in clinical development.
D961S is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company sponsored a Phase 1 clinical trial of the drug in Japan.
D961S is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a bioequivalence study. The drug is investigational and has not been approved by regulatory authorities.
D961S has been studied in one completed Phase 1 clinical trial, identified as NCT01494402. The trial was titled 'Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects' and enrolled 77 participants in Japan.
No, D961S is not the same as esomeprazole/buffered acetylsalicylic acid (ASA). The Phase 1 clinical trial was designed to assess whether D961S is bioequivalent to the combination of esomeprazole and buffered ASA, meaning the study compared the two treatments to evaluate their similarity in the body.