Healthy Volunteers
Conditions
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.
Interventions
DRUGDotilavir sodium tablet
The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.
DRUGDotilavir sodium tablet(Tivicay@)
The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 31days | Collection of adverse events |
| Incidence of abnormal blood pressure | 31 days | Monitor both systolic and diastolic blood pressure |
Countries
China
Contacts
Primary Contactyu Cao, doctor
Outcome results
None listed