Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population
NCT00810316
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- Healthy male or female volunteers aged between 18 and 40 years old.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population | |||
Official Title ICMJE | Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) | |||
Condition ICMJE | Pharmacokinetics | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 24 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2008 | |||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 40 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Mexico | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00810316 | |||
Other Study ID Numbers ICMJE | A6131015 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |