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Excretion of Rivaroxaban in Human Breast Milk (LACT)
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.
Details
| Lead sponsor | Thomas Jefferson University |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 10 |
| Start date | 2025-07 |
| Completion | 2026-07-31 |
Conditions
- Postpartum
- VTE Prophylaxis
- VTE (Venous Thromboembolism)
- Rivaroxaban
- Breastfeeding
- Breast Milk Collection
Interventions
- Rivaroxaban 10 MG Oral Tablet
- Rivaroxaban 20 MG Oral Tablet
Primary outcomes
- Concentration of rivaroxaban in breast milk — Postpartum day 1
Time/Concentration profile of rivaroxaban in breast milk prior to intake (0) and 3, 6, 12, 15 and 24 hours following morning dose on day 0-1 - Concentration of rivaroxaban in breast milk — Postpartum week 6
Time/concentration profile of rivaroxaban in breast milk 3 hours following morning dose on day 2 and onward - Absolute infant dose of rivaroxaban — 6 week postpartum
The absolute infant dose is calculated from average drug concentrations in breast milk multiplied by an estimated breast milk intake of 150 mL/kg/day. - Relative infant dose — 6 weeks postpartum
The relative infant dose is the absolute infant dose expressed as a percentage of the weight adjusted maternal dose, based on an average maternal weight of 75 kg. It is expressed in mg/kg/day.
Countries
United States