Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Alprazolam XR; Drug: Alprazolam; Drug: Clonazepam

• Registration Number: NCT00810316
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy male or female volunteers aged between 18 and 40 years old.

Exclusion Criteria

• Subjects presenting changes on their vital signs constants registered at volunteers' screening.
• Volunteers with any of the following: noncompliance of proposed inclusion criteria; requiring another drug product throughout the study conduction; pregnant or nursing females; history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal, neurological, endocrine, psychiatric, hematopoietic or any other anemia kind, disease, asthma, or organic disorder; history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer or any condition possibly affecting drug absorption; history of acute narrow or glaucoma; exposed to drug products known as hepatic enzyme or inductors; who had received any drug product within 14 days or 5 half lives; who had been hospitalized due to any problem within 60 days prior to study start; history of sensitivity to BZD; who had drink alcohol or any beverage containing xanthines or who had taken smoked food or grapefruit juice within 72 hours prior to start hospitalization period, who had blood donated or lost 450 mL or more within 60 days prior to study start; requiring any special diet regardless the cause.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment B	Alprazolam XR	-
Treatment A	Alprazolam	-
Treatment C	Clonazepam	-

Primary Outcome Measures

Name	Time	Method
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
Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile.	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
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

Secondary Outcome Measures

Name	Time	Method
No Secondary Outcomes

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇲🇽 Col. Arenal Tepepan, Mexico D.F., Mexico