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A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women

Last updated on March 15, 2019

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Lactating Women
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy lactating females between the ages of 18 and 45 years (inclusive) who are
actively breast-feeding or expressing breast milk and are at least 12 weeks post
partum.

- Subjects must be willing to temporarily discontinue breast feeding their infants
before the Day 1 evening dose through to 42 hours after the last dose

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- History of significant adverse reaction to pregabalin or gabapentin.

- Subjects pregnant or unwilling or unable to comply with the Lifestyle guidelines
presented in the protocol during the study period and through the follow-up visit.

- Subjects with evidence or history of clinically significant hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric
(including post natal depression), neurologic or allergic disease (including drug
allergies, but excluding untreated asymptomatic, seasonal allergies at time of
dosing).

NCT01727791
Pfizer
Completed
A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women

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[email protected]

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