NCT07510529

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Simcere Pharmaceutical Co., Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single-center, open-label, randomized, two-sequence, two-period crossover study to assess the relative bioavailability of two formulations. The test product (T) is the 0.2 g/sachet formulation, and the reference product (R) is the 0.1 g/sachet formulation. The formulations are not identical. The study plans to enroll 48 healthy participants, male and female, who will be randomized in a 1:1 ratio to two dosing sequences (T-R and R-T), with 24 participants per sequence. The administered dose per period is 0.2 g for both T and R. 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. 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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-05-31
• Completion: 2026-06-30
• First posted: 2026-04-03
• Last updated: 2026-04-03