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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05168176
• Other study ID #: QL-YK1-045-001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2021
• Source: The Affiliated Hospital of Qingdao University
• Contact: yu Cao, doctor
• Phone: 86 18661809090
• Email: caoyu1767[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Dotilavir sodium tablet
The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.
• Dotilavir sodium tablet(Tivicay@)
The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	31 days
Primary	Area under the plasma concentration versus time curve (AUC0-t)	Evaluation of Area under the plasma concentration versus time curve (AUC0-t)	31days
Primary	Area under the plasma concentration versus time curve (AUC0-8)	Evaluation of Area under the plasma concentration versus time curve (AUC0-8)	31days
Secondary	Incidence of Treatment-Emergent Adverse Events	Collection of adverse events	31days
Secondary	Incidence of abnormal blood pressure	Monitor both systolic and diastolic blood pressure	31 days