A 5-treatment, Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release (CR) Pregabalin Tablet Formulations and the Immediate Release (IR) Formulation Administered Fasted
NCT ID: NCT01443169
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
16 participants
INTERVENTIONAL
2012-03-31
2012-04-30
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
BASIC_SCIENCE
NONE
Study Groups
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Sequence 1
Sequence 1 - Treatment A: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment B: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment C:Controlled Release Pregabalin
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment D: Controlled Release Pregabalin
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment E: Immediate Release Pregabalin
300 mg IR capsule administered in the evening in the fasted state.
Sequence 2
Sequence 2 - Treatment B: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment D: Controlled Release Pregabalin
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment A: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment C: Controlled Release Pregabalin
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment E: Immediate Release Pregabalin
300 mg IR capsule administered in the evening in the fasted state.
Sequence 3
Sequence 3 - Treatment C: Controlled Release Pregabalin
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment A: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment D: Controlled Release Pregabalin
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment B: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment E: Immediate Release Pregabalin
300 mg IR capsule administered in the evening in the fasted state.
Sequence 4
Sequence 4 - Treatment D: Controlled Release Pregabalin
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment C: Controlled Release Pregabalin
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment B: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment A: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment E: Immediate Release Pregabalin
300 mg IR capsule administered in the evening in the fasted state.
Interventions
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Sequence 1 - Treatment A: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment B: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment C:Controlled Release Pregabalin
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment D: Controlled Release Pregabalin
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment E: Immediate Release Pregabalin
300 mg IR capsule administered in the evening in the fasted state.
Sequence 2 - Treatment B: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment D: Controlled Release Pregabalin
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment A: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment C: Controlled Release Pregabalin
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment E: Immediate Release Pregabalin
300 mg IR capsule administered in the evening in the fasted state.
Sequence 3 - Treatment C: Controlled Release Pregabalin
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment A: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment D: Controlled Release Pregabalin
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment B: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment E: Immediate Release Pregabalin
300 mg IR capsule administered in the evening in the fasted state.
Sequence 4 - Treatment D: Controlled Release Pregabalin
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment C: Controlled Release Pregabalin
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment B: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment A: Controlled Release Pregabalin
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment E: Immediate Release Pregabalin
300 mg IR capsule administered in the evening in the fasted state.
Eligibility Criteria
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Inclusion Criteria
* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
* History of febrile illness within 5 days prior to the first dose of study medication.
* Subjects with an estimated creatinine clearance (CLcr) \<60 mL/min derived using the method of Cockcroft and Gault1.
* Any condition possibly affecting drug absorption (eg, gastrectomy, irritable bowel syndrome).
* A positive urine drug screen.
* Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
* 12 lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec at Screening. If QTc exceeds 450 msec or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days (for nonhormonal methods) or approximately 3 months (for hormonal contraception) prior to the first dose of study medication and for 28 days after the last dose of study medication.
* Use of prescription (other than oral, transdermal, intrauterine, implanted, or injected contraceptives or hormone replacement therapy) or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued at least 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis following approval by the sponsor.
* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
* History of sensitivity to pregabalin, gabapentin, or other alpha 2 delta ligands.
* History of sensitivity to heparin or heparin induced thrombocytopenia.
* Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
* Previous participation in a study involving pregabalin.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
* Subjects with active suicidal ideation or suicidal behavior within 1 year prior to Screening as determined through the use of the C-SSRS (Columbia-Suicide Severity Rating Scale) or active ideation identified at Screening or on Day 1.
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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A0081286
Identifier Type: -
Identifier Source: org_study_id
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