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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00810316
First received: December 16, 2008
Last updated: September 30, 2009
Last verified: September 2009

December 16, 2008
September 30, 2009
October 2008
November 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile. [ Time Frame: Sampling times: 0 to 96 hours ] [ Designated as safety issue: No ]
  • t 1/2: Half life time. [ Time Frame: Sampling times: 0 to 96 hours ] [ Designated as 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00810316 on ClinicalTrials.gov Archive Site
No Secondary Outcomes [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population
Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Pharmacokinetics
  • 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 Name: Tafil, Xanax
  • 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 Name: Tafil AP, Xanax XR
  • 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 Name: Rivotril
  • Treatment A
    Intervention: Drug: Alprazolam
  • Treatment B
    Intervention: Drug: Alprazolam XR
  • Treatment C
    Intervention: Drug: Clonazepam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00810316
A6131015
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP