Clinical Trial

A Crossover Study to Evaluate the Relative Bioavailability of Two Formulations of Deuterated Remdesivir Hydrobromide for Oral Suspension in Healthy Chinese Adults

Not Yet Recruiting Phase 1
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Record status
This record was last updated April 3, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
A single-center, open-label, randomized, two-sequence, two-period crossover study in 48 healthy subjects to compare the relative bioavailability of two formulations. The test (T, 0.2 g/sachet) and reference (R, 0.1 g/sachet) are administered at a dose of 0.2 g per period: sequence T-R receives 1 sachet T (period 1) and 2 sachets R (period 2); sequence R-T receives 2 sachets R (period 1) and 1 sachet T (period 2). Subjects are randomized 1:1 to either sequence.
Trial Details
NCT Number NCT07510529
Lead Sponsor Simcere Pharmaceutical Co., Ltd
Conditions Healthy Participants
Enrollment 48 participants
Start Date 2026-04-20
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-03