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Study to determine the relative bioavailability of different oral Viramune Extended Release (ER) formulations compared to Viramune® Immediate Release (IR) tablet
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nevirapine (NVP) ER 300 mg (KCR 20%) Medium Release | Experimental |
| |
| NVP ER 300 mg (KCR 25%) Medium Release | Experimental |
| |
| NVP ER 300 mg (KCR 30%) Slow Release | Experimental |
| |
| NVP ER 400 mg (KCR 25%) Medium Release | Experimental |
| |
| NVP ER 300 mg (KCR 40%) Slow Release | Experimental |
| |
| NVP ER 300 mg (ECR 20%) Fast Release | Experimental |
| |
| NVP ER 400 mg (KCR 20%) Medium Release | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVP ER 300 mg (KCR 20%) Medium Release | Drug |
| ||
| NVP ER 300 mg (KCR 25%) Medium Release |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 144 hours post-dose | |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 144 hours post-dose | |
| C24 (measured concentration of the analyte in plasma at 24 hours post-dose) | 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax/C24 ratio | up to 144 hours post-dose | |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 144 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| NVP ER 400 mg (KCR 30%) Slow Release | Experimental |
|
| NVP ER 400 mg (KCR 40%) Slow Release | Experimental |
|
| NVP ER 400 mg (ECR 20%) Fast Release | Experimental |
|
| Nevirapine IR 1 tablet | Active Comparator |
|
| Nevirapine IR 2 tablets | Active Comparator |
|
| Drug |
|
| NVP ER 300 mg (KCR 30%) Slow Release | Drug |
|
| NVP ER 400 mg (KCR 25%) Medium Release | Drug |
|
| NVP ER 300 mg (KCR 40%) Slow Release | Drug |
|
| NVP ER 300 mg (ECR 20%) Fast Release | Drug |
|
| NVP ER 400 mg (KCR 20%) Medium Release | Drug |
|
| NVP ER 400 mg (KCR 30%) Slow Release | Drug |
|
| NVP ER 400 mg (KCR 40%) Slow Release | Drug |
|
| NVP ER 400 mg (ECR 20%) Fast Release | Drug |
|
| Nevirapine immediate release (IR) 200 mg | Drug |
|
| λz (terminal rate constant in plasma) | up to 144 hours post-dose |
| t1/2 (terminal half-life of the analyte in plasma) | up to 144 hours post-dose |
| MRTpo (mean residence time of the analyte in the body after po administration) CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | up to 144 hours post-dose |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 144 hours post-dose |
| ka (absorption rate constant) | up to 144 hours post-dose |
| Number of patients with adverse events | up to 36 days |
| Assessment of tolerability by investigator on a 4-point scale | within 8 days after last trial procedure |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | up to 144 hours post-dose |
| ID | Term |
|---|---|
| D019829 | Nevirapine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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