Multiple dose Study to evaluate concentration of Lyrica in lactating women

A MULTIPLE DOSE PHARMACOKINETIC OPEN-LABEL STUDY OF PREGABALIN (LYRICA) IN HEALTHY LACTATING WOMEN

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003197-57-BE

Enrollment

Unknown

Registered

2012-10-11

Start date

2012-11-09

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuropathic pain associated with diabetic peripheral neuropathy postherpetic neuralgia neuropathic pain related to spinal cord injury (US), fibromyalgia (US, JP) treatment of central and peripheral neuropathic pain (EU) the treatment of peripheral neuropathic pain (JP) adjunctive treatment of partial onset seizures (US and EU) generalized anxiety disorder (EU). MedDRA version: 15.1 Level: LLT Classification code 10028005 Term: Motor peripheral neuropathy System Organ Class: 10029205 - Ner

Interventions

Trade Name: Lyrica Product Name: Pregabalin Pharmaceutical Form: Capsule, hard INN or Proposed INN: PREGABALIN CAS Number: 148553-50-8 Other descriptive name: PREGABALIN Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy lactating females who are actively breast-feeding or expressing breast milk, who are at least 12 weeks post partum and not currently pregnant, and who are between the ages of 18 and 45 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine pregabalin drug concentrations in human breast milk and estimate the infant daily dose that would result from pregabalin secretion in breast milk.;Secondary Objective: To characterize the safety and tolerability of pregabalin in lactating women.;Primary end point(s): Pharmacokinetics - Pregabalin pharmacokinetics in plasma and breast milk. - Mean and concentration range of pregabalin in breast milk. - Mean and range for infant daily dose of pregabalin, based on reference ranges for the volume of infant breast milk consumption. - Pregabalin urine pharmacokinetics Safety - Safety and tolerability of pregabalin as determined by adverse event reporting, clinical laboratory results and vital signs.;Timepoint(s) of evaluation of this end point: All study long	—

Measure

Time frame

Main Objective: To determine pregabalin drug concentrations in human breast milk and estimate the infant daily dose that would result from pregabalin secretion in breast milk.;Secondary Objective: To characterize the safety and tolerability of pregabalin in lactating women.;Primary end point(s): Pharmacokinetics - Pregabalin pharmacokinetics in plasma and breast milk. - Mean and concentration range of pregabalin in breast milk. - Mean and range for infant daily dose of pregabalin, based on reference ranges for the volume of infant breast milk consumption. - Pregabalin urine pharmacokinetics Safety - Safety and tolerability of pregabalin as determined by adverse event reporting, clinical laboratory results and vital signs.;Timepoint(s) of evaluation of this end point: All study long

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Countries

Belgium

Contacts

Public ContactDr. Erik Brouwer

Pfizer Worldwide Research and Development

Erik.Brouwer2@pfizer.com3225567020

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026