Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters (C\~max) of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension (test vs. reference)
From enrollment to Day10
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters (AUC\~0-t) of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension (test vs. reference)
From enrollment to Day10
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters (AUC\~0-∞) of the main metabolite 116-N1 after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension (test vs. reference)
From enrollment to Day10

Secondary Outcomes (6)

Primary PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
From enrollment to Day10
Primary PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
From enrollment to Day10
Primary PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
From enrollment to Day10
PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
From enrollment to Day10
PK parameters of the main metabolite after a single oral dose of 0.2 g of Deuterated Remdesivir Hydrobromide for Oral Suspension
From enrollment to Day10
+1 more secondary outcomes

Study Arms (2)

SIM0916（0.2 g）

EXPERIMENTAL

Drug: T-R (Test-Reference drug)Drug: R-T (Reference-Test drug)

SIM0916（0.1g）

ACTIVE COMPARATOR

Drug: T-R (Test-Reference drug)Drug: R-T (Reference-Test drug)

Interventions

T-R (Test-Reference drug)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

SIM0916（0.1g）SIM0916（0.2 g）

R-T (Reference-Test drug)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

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Able to read, understand, voluntarily participate, and sign the informed consent form.
Aged 18 to 50 years (inclusive) at screening, male or female.

Sponsors & Collaborators

Simcere Pharmaceutical Co., Ltd
Otherlead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, China

Study Officials

xiaojiao Li
The First Hospital of Jilin University
PRINCIPAL INVESTIGATOR

Enrollment

48 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 3, 2026

Study Start

April 17, 2026

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Study Arms (2)

SIM0916（0.2 g）

SIM0916（0.1g）

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Study Arms (2)

SIM0916（0.2 g）

SIM0916（0.1g）

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations