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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03341013 | A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382 | PHASE1 | COMPLETED | 24 | — | — | Nov 30, 2017 | Jan 29, 2018 | Feb 14, 2018 | 1 | United States |
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | formulation 2 on Day 1 and formulation 3 on Day 10 |
| Sequence 2 | EXPERIMENTAL | formulation 3 on Day 1 and formulation 2 on Day 10 |
| Name | Type | Description |
|---|---|---|
| MEDI0382 Formulation 2 | DRUG | Sequence 1 Period 1 and Sequence 2 Period 2. |
| MEDI0382 Formulation 3 | DRUG | Sequence 1 Period 2 and Sequence 2 Period 1 |
Inclusion Criteria: 1. Healthy subjects age 18 through 45 years at the time of screening. 2. Provision of signed and dated written informed consent prior to study-specific procedures. 3. Body mass index between 19 and 30 kg/m2 (inclusive) at screening 4. Good general health as judged by the investi...