drugset / Trial / NCT01727791

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

NCT01727791

Phase 4 Completed 10 enrolled Viatris Inc.
Non-randomizedOpen-labelOther

Summary

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 women.

Timeline

Start
2012-12
Primary completion
2013-08
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 150 mg

Indications

No indication recorded.