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

Pharmacokinetics Clinical Trial

Official title:

Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810316
• Other study ID #: A6131015
• Status: Completed
• Phase: Phase 1
• Start date: October 2008
• Est. completion date: November 2008

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Alprazolam
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
• Alprazolam XR
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
• Clonazepam
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

Locations

Country	Name	City	State
Mexico	Pfizer Investigational Site	Col. Arenal Tepepan	Mexico D.F.

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	AUC inf: Area under the curve of plasma concentration from administration up to infinitum extrapolated time.		Sampling times: 0 to 96 hours
Primary	Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile.		Sampling times: 0 to 96 hours
Primary	t 1/2: Half life time.		Sampling times: 0 to 96 hours
Primary	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	No Secondary Outcomes

External Links

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