Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03456960 | A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet | PHASE1 | COMPLETED | 276 | — | — | Mar 8, 2018 | Oct 12, 2018 | Nov 19, 2019 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin | EXPERIMENTAL | One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in the Pilot phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 2 in the Pilot phase of Study 1 (Day 16). |
| Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA | EXPERIMENTAL | One TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 1 in the Pilot phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by, one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in the Pilot phase of Study 1 (Day 16). |
| Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin | EXPERIMENTAL | One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in the Pivotal phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 2 in the Pivotal phase of Study 1 (Day 16). |
| Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA | EXPERIMENTAL | One TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 1 in the Pivotal phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in the Pivotal phase of Study 1 (Day 16). |
| Study 2,TAK-438ASA (Fasted + Fed condition) | EXPERIMENTAL | One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in Study 2 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally 30 minutes after breakfast, on Day 1 of Period 2 in Study 2 (Day 16). |
| Study 2,TAK-438ASA (Fed + Fasted condition) | EXPERIMENTAL | One TAK-438ASA tablet, orally 30 minutes after breakfast, on Day 1 of Period 1 in Study 2 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in Study 2 (Day 16). |
| Name | Type | Description |
|---|---|---|
| TAK-438ASA | DRUG | TAK-438ASA tablet. |
| TAK-438 | DRUG | TAK-438 tablet. |
| Aspirin | DRUG | Aspirin enteric-coated tablet. |
Inclusion Criteria: 1. In the opinion of the investigator or sub-investigator, participants are capable of understanding the procedures required for the study and complying with its requirements. 2. Participants sign and date an informed consent form by themselves prior to the initiation of any stu...