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NOT YET RECRUITING
NCT07510529
PHASE1

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

Sponsor: Simcere Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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.

Official title: A Single-Center, Open-Label, Randomized, Two-Sequence, Two-Period Crossover Study to Evaluate the Relative Bioavailability of Two Formulations of Deuterated Remdesivir Hydrobromide for Oral Suspension in Healthy Chinese Adult Participants

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-04-20

Completion Date

2026-06-30

Last Updated

2026-04-03

Healthy Volunteers

Yes

Interventions

DRUG

T-R (Test-Reference drug)

Participants in the T-R sequence receive 1 sachet of the test product (T) in Period 1 and 2 sachets of the reference product (R) in Period 2

DRUG

R-T (Reference-Test drug)

Participants in the R-T sequence receive 2 sachets of the reference product (R) in Period 1 and 1 sachet of the test product (T) in Period 2