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

Qingdao University

Status and phase

Unknown

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Dotilavir sodium tablet

Drug: Dotilavir sodium tablet(Tivicay@)

Study type

Interventional

Funder types

Other

Identifiers

NCT05168176

QL-YK1-045-001

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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;