An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule
NCT ID: NCT01009541
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2009-11-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Pregabalin controlled release, 82.5 mg
Pregabalin controlled release, 82.5 mg
82.5 mg controlled release tablet administered once daily for three days.
Pregabalin controlled release, 165 mg
Pregabalin controlled release, 165 mg
165 mg controlled release tablet administered once daily for three days.
Pregabalin controlled release, 330 mg
Pregabalin controlled release, 330 mg
330 mg controlled release tablet administered once daily for three days.
Pregabalin immediate release, 150 mg
Reference Treatment
Pregabalin immediate release, 150 mg
150 mg immediate release capsules administered every 12 hours for three days
Interventions
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Pregabalin controlled release, 82.5 mg
82.5 mg controlled release tablet administered once daily for three days.
Pregabalin controlled release, 165 mg
165 mg controlled release tablet administered once daily for three days.
Pregabalin controlled release, 330 mg
330 mg controlled release tablet administered once daily for three days.
Pregabalin immediate release, 150 mg
150 mg immediate release capsules administered every 12 hours for three days
Eligibility Criteria
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Inclusion Criteria
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
Exclusion Criteria
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Brussels, , Belgium
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081225
Identifier Type: -
Identifier Source: org_study_id
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