MedTrace Logo

Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects in the Fasting and Fed State

NCT05168176 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-12-23

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the bioequivalence of two dotilavir sodium tablets in the fasting and fed state. The secondary purpose of this study is to observe the safety of the test and reference preparations. An open-label, randomized, single-dose, crossover study in healthy Chinese volunteers was performed. A single oral dose of 50 mg of two dotilavir sodium tablets was administered to 64 healthy volunteers, with 36 in the fasted group and 28 consuming a high-fat diet. The evaluated pharmacokinetic parameters, including maximum concentration (Cmax), the area under the concentration-time curve (AUC0-t and AUC0-∞) were assessed for bioequivalence.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Dotilavir sodium tablet

The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.

DRUG

Dotilavir sodium tablet(Tivicay@)

The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2021-12-31
Completion
2022-01-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05168176 on ClinicalTrials.gov