Clinical trial NCT00810316: Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Alprazolam
Alprazolam extended release
Clonazepam
Pharmacokinetics
Mexican population
Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: AUC last: Area under the curve of plasma concentration from administration up to time t (last sampling timepoint) calculated by trapezoid method.
timeFrame: Sampling times: 0 to 96 hours
measure: AUC inf: Area under the curve of plasma concentration from administration up to infinitum extrapolated time.
timeFrame: Sampling times: 0 to 96 hours
measure: Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile.
timeFrame: Sampling times: 0 to 96 hours
measure: t 1/2: Half life time.
timeFrame: Sampling times: 0 to 96 hours
measure: Tmax: Time from administration up to maximum plasma concentration, graphically obtained based on plasma concentration versus time profile.
timeFrame: Sampling times: 0 to 96 hours
Secondary outcomes:
measure: No Secondary Outcomes
Other outcomes:
Locations:
city: Col. Arenal Tepepan
country: Mexico
facility: Pfizer Investigational Site
state: Mexico D.F.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: