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

NCT00810316 | Completed Phase 1

• 1 other identifier: A6131015
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Keywords

Alprazolam; Alprazolam extended release; Clonazepam; Pharmacokinetics; Mexican population; Healthy

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (1)

• No Secondary Outcomes

Study Arms (3)

Treatment A

OTHER

Drug: Alprazolam

Treatment B

OTHER

Drug: Alprazolam XR

Treatment C

OTHER

Drug: Clonazepam

Interventions

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

Also known as: Tafil, Xanax

Treatment A

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

Also known as: Tafil AP, Xanax XR

Treatment B

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

Also known as: Rivotril

Treatment C

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Subjects presenting changes on their vital signs constants registered at volunteers' screening.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (1)

Pfizer Investigational Site

Col. Arenal Tepepan, Mexico City, 14610, Mexico

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Alprazolam; Clonazepam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepinones

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 18, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

ME (1)