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Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers

Last updated on March 14, 2019

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Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Healthy female subjects and/or male subjects who, at the time of screening, are
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
electrocardiogram (ECG) or clinical laboratory tests. A 1:1 ratio of men to women is
desirable, but it will not be considered a protocol deviation if this is not met.

2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

3. Evidence of a personally signed and dated informed consent document.

4. Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).

2. History of febrile illness within 5 days prior to the first dose of study
investigational product.

3. Subjects with an estimated CLcr Gault.1

4. Any condition possibly affecting drug absorption.

5. A positive urine drug screen.

6. Use of tobacco or nicotine containing products in excess of the equivalent of 5
cigarettes per day.

7. History of regular alcohol consumption exceeding 7 drinks/week for females or 14
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.

8. Treatment with an investigational drug within 30 days or 5 half lives preceding the
first dose of study investigational product (whichever is longer).

9. Screening supine blood pressure >= 140 mm Hg (systolic) or >= 90 mm Hg (diastolic),
following at least 5 minutes of supine rest. If blood pressure is >= 140 mm Hg
(systolic) or >= 90 mm Hg (diastolic), the blood pressure should be repeated 2 more
times and the average of the 3 blood pressure values should be used to determine the
subject's eligibility.

10. Screening supine 12 lead ECG demonstrating QTc (time from ECG Q wave to the end of the
T wave corresponding to electrical systole [QT] corrected for the heart rate) >450
msec or a QRS interval (time from ECG Q wave to the end of the S wave corresponding to
ventricle depolarization) >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec,
the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values
should be used to determine the subject's eligibility.

11. Pregnant female subjects; breastfeeding female subjects; male subjects with partners
currently pregnant; male subjects able to father children and female subjects of
childbearing potential who are unwilling or unable to use a highly effective method of
contraception as outlined in this protocol for the duration of the study and for at
least 28 days after the last dose of investigational product.

12. 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.investigational product. Herbal supplements must be
discontinued at least 28 days prior to the first dose of study
medicationinvestigational product. As an exception, acetaminophen/paracetamol may be
used at doses of greater than 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.

13. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.

14. History of sensitivity to pregabalin, gabapentin, or other alpha2 delta ligands.

15. History of sensitivity to heparin or heparin induced thrombocytopenia.

16. Unwilling or unable to comply with the Lifestyle Guidelines described in this
protocol.

17. Previous participation in a study involving pregabalin.

18. Subjects who are investigational site staff members directly involved in the study,
their family members, site staff members otherwise supervised by the investigator, or
subjects who are Pfizer employees directly involved in the study.

19. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation.

NCT02725112
Pfizer
Completed
Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers

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