NCT06749236

A Study to Evaluate the Bioavailability of Two Specifications of Oral Deuremidevir Hydrobromide for Suspension

A Single-center, Randomized, Open-label, Two-period, Crossover Clinical Study to Evaluate the Bioavailability of Two Specifications of Oral Deuterium Deuremidevir for Hydrobromide Suspension in Chinese Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical study is to evaluate the bioavailability of two specifications of oral Deuteriumremidvir Hydrobromide for suspension in Chinese healthy adult participants. A total of 18 participants are planned to be enrolled and randomized into T-R or R-T sequence, 9 in each sequence with a single fasting administration in each period.

Detailed description

This is a single-center, randomized, open-label, two-period, crossover clinical study to evaluate the bioavailability of two specifications of oral deuteriumremidvir hydrobromide for suspension. With a washout period of 3 days, the dose is 200 mg in each sequence. The specification of the test formulation(T) is 200 mg and that for the reference formulation (R) is 100 mg. A total of 18 participants are planned to be enrolled and randomized into T-R or R-T sequence, 9 in each sequence with a single fasting administration in each period.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	test formulation(T) 200 mg deuteriumremidvir hydrobromide for suspension	Participants will receive a single dose of the test formulation(T) (one bag of 200 mg deuteriumremidvir hydrobromide for suspension).
DRUG	reference formulation(R) 100 mg deuteriumremidvir hydrobromide for suspension	Participants will receive a single dose of the reference formulation(R) ( two bags of 100 mg deuteriumremidvir hydrobromide for suspension).

Timeline

• Start date: 2025-08-11
• Primary completion: 2025-08-20
• Completion: 2025-09-03
• First posted: 2024-12-27
• Last updated: 2025-11-21

Locations

1 site across 1 country: China