A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Lactating Women
Intervention: pregabalin (Lyrica) (Drug)
Phase: Phase 4
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in
healthy lactating women. The objectives are to determine whether pregabalin is secreted in
breast milk and if so, to characterize pregabalin pharmacokinetics in breast milk. Other
objectives are to estimate potential infant exposure to pregabalin if administered to
lactating women and to characterize the safety and tolerability of pregabalin in lactating
Official title: A Multiple Dose Pharmacokinetic Open Label Study Of Pregabalin (Lyrica) In Healthy Lactating Women
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Ae.tau.urine [Amount recovered in urine during the dosing interval, tau (12 hours)]
"Area Under the Curve from Time Zero to end of dosing interval (AUCtau) (plasma and breast milk)"
Clr [Renal clearance; Urine Ae(tau)/ Plasma AUC(tau)]
"Maximum Observed Plasma Concentration (Cmax) (plasma and breast milk)"
"Time to Reach Maximum Observed Plasma Concentration (Tmax) (plasma and breast milk)"
"Half-Life (t1/2) (plasma)"
Caverage (plasma only)
Minimum Observed Plasma Trough Concentration (Cmin) (plasma only)
Apparent Oral Clearance (CL/F) (plasma only)
Ae.tau.bm [Amount excreted in breast milk over the dosing interval tau (12 hours)]
"CL.bm [Breast milk clearance Ae(tau)bm/plasma AUC(tau)]"
"Half-Life (t1/2) ( breast milk)"
Post approval commitment for the FDA
Minimum age: 18 Years.
Maximum age: 45 Years.
- 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
- 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
- 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
Locations and Contacts
Pfizer Clinical Research Unit, Brussels B-1070, Belgium
To obtain contact information for a study center near you, click here.
Starting date: December 2012
Last updated: August 23, 2013