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Excretion of Rivaroxaban in Human Breast Milk

NCT06831474 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-07-17

No results posted yet for this study

Summary

The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.

Conditions

  • Postpartum
  • VTE Prophylaxis
  • VTE (Venous Thromboembolism)
  • Rivaroxaban
  • Breastfeeding
  • Breast Milk Collection

Interventions

DRUG

Rivaroxaban 10 MG Oral Tablet

10mg rivaroxaban daily

DRUG

Rivaroxaban 20 MG Oral Tablet

20mg rivaroxaban daily

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-04-01
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06831474 on ClinicalTrials.gov