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This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy subjects
This is a Phase 1 study to evaluate the PK profile of different oral formulations of TXL following single dose administration in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Active Comparator | Immediate release tablet Tenofovir exalidex (TXL) |
|
| Regimen B | Experimental | New Formulation 1 Tenofovir exalidex (TXL) |
|
| Regimen C | Experimental | New formulation 2 Tenofovir exalidex (TXL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir exalidex (TXL) | Drug | Oral formulations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state | Measuring Cmax, the peak plasma concentration | up to four days post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Sullivan-Bolyai, MD, MPH | ContraVir Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Nottingham | United Kingdom |
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Drug: Tenofovir Exalidex (TXL) oral formulations Other names: Lipid conjugateTFV
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