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The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants.
The secondary objective is to evaluate the safety and tolerability of TEV-56286.
The planned duration for each participant is approximately 70 days which includes a 45 day screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Random sequence of test and reference formulations |
|
| Cohort 2 | Experimental | Random sequence of test and reference formulations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEV-56286 Test | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Drug Concentration (Cmax) | Up to Day 17 | |
| Area Under the Drug Concentration-Time Curve from Time 0 to Last Measurable Drug Concentration [AUC(0-t)] | Up to Day 17 | |
| Area Under the Drug Concentration-Time Curve from Time 0 to Infinity [AUC(0-inf)] | Up to Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with at least one treatment-emergent adverse event | Up to Day 26 | |
| Number of participants who did not complete the trial due to an adverse event | Up to Day 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 12141 | Miramar | Florida | 33025 | United States |
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| TEV-56286 Reference | Drug | Administered orally |
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