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

Phase 1

• Conditions: Healthy Volunteers
• Interventions: Drug: Dotilavir sodium tablet; Drug: Dotilavir sodium tablet(Tivicay@)

• Registration Number: NCT05168176
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-01
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Last Update Submitted: 2021-12-08
• Study First Posted: 2021-12-23
• Last Update Posted: 2021-12-23
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Healthy male or female subjects ≥18 years of age, with appropriate sex ratio
• The body mass index is in the range of 19.0-27.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg
• The subjects have no family planning within 3 months and could select contraceptive method.
• Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily

Exclusion Criteria

• Subjects with allergic constitution.
• Being allergy to the study medications, smoking, alcohol abuse.
• Participation in another clinical trial within 3 months.
• Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening;
• Hepatitis (including hepatitis B and C), positive screening results for AIDS or syphilis;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dotilavir sodium tablet	Dotilavir sodium tablet	-
Dotilavir sodium tablet(Tivicay@)	Dotilavir sodium tablet(Tivicay@)	-

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	31 days	Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)	31days	Evaluation of Area under the plasma concentration versus time curve (AUC0-t）
Area under the plasma concentration versus time curve (AUC0-∞)	31days	Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)

Secondary Outcome Measures

Name	Time	Method
Incidence of abnormal blood pressure	31 days	Monitor both systolic and diastolic blood pressure
Incidence of Treatment-Emergent Adverse Events	31days	Collection of adverse events

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China