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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00810316

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

23.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: Alprazolam Drug: Alprazolam XR Drug: Clonazepam	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: Treatment A	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 Other Names: Tafil, Xanax
Other: Treatment B	Drug: 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 Other Names: Tafil AP, Xanax XR
Other: Treatment C	Drug: 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 Other Names: Rivotril

Arm

Intervention/Treatment

Other: Treatment A

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

Other Names:

Tafil, Xanax

Other: Treatment B

Drug: 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

Other Names:

Tafil AP, Xanax XR

Other: Treatment C

Drug: 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

Other Names:

Rivotril

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

No Secondary Outcomes []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.