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| Name | Class |
|---|---|
| Investigación Farmacológica y Biofarmacéutica | UNKNOWN |
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The purpose of this study is to compare the bioavailability of two oral formulations of Triazolam in healthy volunteers, in order to determine that they are bioequivalent.
The bioequivalence trial of triazolam is due to change in manufacture site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triazolam Reference Arm | Active Comparator | There will be a clearance period of at least 3 days between the two phases of the study. |
|
| Triazolam Trial Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triazolam | Drug | Tablets, 0.25 mg, single-dose, 1 period of 3 three days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-∞) of the two formulations of Triazolam in tablets | Day 1 and two after dosage is taken | |
| Statistically compare the bioavailability of the pharmaceutical formulations of Triazolam studied, to establish or rule out the existence of bioequivalence | Six to eight weeks after completing the study, a final report will be prepared. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the safety of both preparations based on the record of adverse events on completing both study periods | Up to 3 days after the 2nd period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Triazolam |
| Drug |
Tablets, 0.25 mg, single-dose, 1 period of 3 three days. |
|
| ID | Term |
|---|---|
| D014229 | Triazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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