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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Dotilavir sodium tablet; Drug: Dotilavir sodium tablet(Tivicay@)

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Recruiting
      • The Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Dolutegravir
• Other Study ID Numbers: QL-YK1-045-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No