Conditions: Healthy Lactating Women
Keywords: pharmacokinetic pregabalin lactation
Allocation: NON_RANDOMIZED | Intervention model: 
Enrollment: 10
Healthy volunteers: yes

Brief 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.

Detailed description:
Post approval commitment for the FDA

Arms:
arm 1: None

Interventions: intervention 1: pregabalin (Lyrica)
Intervention descriptions: intervention 1: Subjects will receive a single 150 mg dose of pregabalin in the evening of Day 1, a 150 mg dose of pregabalin in the morning and evening of Day 2 and a 150 mg dose in the morning of Day 3.

Protocol document: