Pfizer Investigational Site
Col. Arenal Tepepan, Mexico City, 14610, Mexico
NCT Number: NCT00810316
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.
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Notify Me18 year–40 year
All sexes
Interventional
Phase 1
Col. Arenal Tepepan, Mexico City, 14610, Mexico
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Tafil, Xanax
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
Other names: Tafil AP, Xanax XR
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
Other names: Rivotril
Time frame: Sampling times: 0 to 96 hours
Time frame: Sampling times: 0 to 96 hours
Time frame: Sampling times: 0 to 96 hours
Time frame: Sampling times: 0 to 96 hours
Time frame: Sampling times: 0 to 96 hours
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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