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Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk.

NCT03710395 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-10-18

No results posted yet for this study

Summary

This study aims to investigate the influence of the c.421C\>A genetic polymorphism of the ABCG2 / BCRP transporter in the concentration ratio of nifedipine in maternal milk:plasma in hypertensive breastfeeding women attended at the Gynecology and Obstetrics Service of the Medical School of Ribeirão Preto, of the University of São Paulo. Thus, plasma and breast milk samples are being collected from patients in chronic use of the drug (n=30) within 15 to 30 days postnatal.

Conditions

  • Drug Transporter

Interventions

PROCEDURE

Blood and breast milk sampling

At least 15 days after starting treatment with 20 mg slow-release nifedipine every 12 hours. Blood and breast milk will be sampled before first dosing in the morning.

DRUG

Nifedipine

Chronic hypertensive breastfeeding women will be treated with slow-release 20 mg nifedipine, twice a day.

Sponsors & Collaborators

  • Hospital das Clínicas de Ribeirão Preto

    collaborator OTHER

  • Natalia Valadares de Moraes

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-14
Primary Completion
2018-02-01
Completion
2019-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03710395 on ClinicalTrials.gov