Official Title: “Pharmacokinetic Comparison Among Two Alprazolam Formulations (Immediate-Release And Modified-Release) And A Clonazepam Formulation In Healthy Volunteers”

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.

Study Type: Interventional

Study Design: Other, Randomized, Single Blind (Subject), Parallel Assignment, Pharmacokinetics Study

Study Primary Completion Date: November 2008

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.

Intervention(s) in this Clinical Trial

• 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
• 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
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Other: Treatment A
• Other: Treatment B
• Other: Treatment C

Primary Measures

• AUC last: Area under the curve of plasma concentration from administration up to time t (last sampling timepoint) calculated by trapezoid method.
  • Time Frame: Sampling times: 0 to 96 hours
    Safety Issue?: No
• AUC inf: Area under the curve of plasma concentration from administration up to infinitum extrapolated time.
  • Time Frame: Sampling times: 0 to 96 hours
    Safety Issue?: No
• Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile.
  • Time Frame: Sampling times: 0 to 96 hours
    Safety Issue?: No
• t 1/2: Half life time.
  • Time Frame: Sampling times: 0 to 96 hours
    Safety Issue?: No
• Tmax: Time from administration up to maximum plasma concentration, graphically obtained based on plasma concentration versus time profile.
  • Time Frame: Sampling times: 0 to 96 hours
    Safety Issue?: No

Secondary Measures

• No Secondary Outcomes
  • Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00810316

Study ID Number: A6131015

ClinicalTrials.gov Identifier: NCT00810316

Health Authority: Mexico: Ministry of Health

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