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oral administration test 2:fasting Reference drug-fasting test drug-fed Reference drug-fed test drug

2 trials

Sponsors

The Second Affiliated Hospital of Anhui Medical University, The Second Hospital of Anhui Medical University

Conditions

Treatment of bleeding due to vitamin K deficiency and prevention of vitamin K deficiency that cannot be alleviated by nutritional therapyUsed to relieve occasional insomnia, especially when accompanied by mild pain

Phase 1

Pre-test of bioequivalence of vitamin K1 injection (1mL:10mg) under oral and injectable conditions in healthy Chinese subjects
Active, not recruitingChiCTR2300070033
The Second Affiliated Hospital of Anhui Medical UniversityTreatment of bleeding due to vitamin K deficiency and prevention of vitamin K deficiency that cannot be alleviated by nutritional therapy
Start: 2023-03-31Updated: 2023-05-29

Unknown Phase

Randomized, open-label, single-dose, two-formulation, two-sequence, two-cycle, double-cross-over bioequivalence study of Diphenhydramine Citrate and Ibuprofen Tablets in healthy subjects under fasting/postprandial administration conditions
Active, not recruitingChiCTR2500106504
The Second Hospital of Anhui Medical UniversityUsed to relieve occasional insomnia, especially when accompanied by mild pain
Start: 2025-03-27Updated: 2025-08-18

Related Papers

Virtual bioequivalence-guided PBBM prediction for ibuprofen/diphenhydramine citrate tablets: impact of dissolution variability and clinical standard development.
2026-09-07