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

Study Overview
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Brief Summary
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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.

Official Title
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Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects: A Single-center, Open, Randomized, Single-dose, Crossover Study

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Dotilavir sodium tablet
* Drug: Dotilavir sodium tablet(Tivicay@)


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dotilavir sodium tablet<br> | Drug: Dotilavir sodium tablet<br>* The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.<br>|
| Active Comparator: Dotilavir sodium tablet(Tivicay@)<br> | Drug: Dotilavir sodium tablet(Tivicay@)<br>* The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 31 days | 
| Area under the plasma concentration versus time curve (AUC0-t) | Evaluation of Area under the plasma concentration versus time curve (AUC0-t） | 31days | 
| Area under the plasma concentration versus time curve (AUC0-∞) | Evaluation of Area under the plasma concentration versus time curve (AUC0-∞) | 31days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Collection of adverse events | 31days | 
| Incidence of abnormal blood pressure | Monitor both systolic and diastolic blood pressure | 31 days |