Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00810316
First received: December 16, 2008
Last updated: September 30, 2009
Last verified: September 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pharmacokinetics |
Drug: Alprazolam Drug: Alprazolam XR Drug: Clonazepam |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
| Official Title: | Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population |
Resource links provided by NLM:
Further study details as provided by Pfizer:
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. [ 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 ]
Secondary Outcome Measures:
- No Secondary Outcomes [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | October 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: Tafil, Xanax
|
| 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 Name: Tafil AP, Xanax XR
|
| 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 Name: Rivotril
|
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| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00810316 History of Changes |
| Other Study ID Numbers: | A6131015 |
| Study First Received: | December 16, 2008 |
| Last Updated: | September 30, 2009 |
| Health Authority: | Mexico: Ministry of Health |
Keywords provided by Pfizer:
|
Alprazolam Alprazolam extended release Clonazepam |
Pharmacokinetics Mexican population Healthy |
Additional relevant MeSH terms:
|
Alprazolam Clonazepam Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anticonvulsants |
ClinicalTrials.gov processed this record on May 16, 2013