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To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release, and clonazepam tablet.
To determine pharmacokinetics of alprazolam and clonazepam in Latin-American population; in Mexico, both drugs are still widely used as first or second choice in the treatment of anxiety disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Other |
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| Treatment B | Other |
| |
| Treatment C | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprazolam | Drug | Administration of a single oral dose tablet of 1 mg of alprazolam immediate release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions |
| Measure | Description | Time Frame |
|---|---|---|
| AUC last: Area under the curve of plasma concentration from administration up to time t (last sampling timepoint) calculated by trapezoid method. | Sampling times: 0 to 96 hours | |
| AUC inf: Area under the curve of plasma concentration from administration up to infinitum extrapolated time. | Sampling times: 0 to 96 hours | |
| Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile. | Sampling times: 0 to 96 hours | |
| t 1/2: Half life time. | Sampling times: 0 to 96 hours | |
| Tmax: Time from administration up to maximum plasma concentration, graphically obtained based on plasma concentration versus time profile. | Sampling times: 0 to 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| No Secondary Outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Col. Arenal Tepepan | Mexico City | 14610 | Mexico |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Alprazolam XR | Drug | Administration of a single oral dose tablet of 1 mg of alprazolam modified release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions |
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| Clonazepam | Drug | Administration of a single oral dose of two tablets of 0.5 mg of clonazepam on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| D002998 | Clonazepam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001570 | Benzodiazepinones |
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