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

NCT05168176 | Unknown Phase 1

• 1 other identifier: QL-YK1-045-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  31days

• Incidence of abnormal blood pressure

  31 days

Study Arms (2)

Dotilavir sodium tablet

EXPERIMENTAL

Drug: Dotilavir sodium tablet

Dotilavir sodium tablet(Tivicay@)

ACTIVE COMPARATOR

Drug: Dotilavir sodium tablet(Tivicay@)

Interventions

Dotilavir sodium tablet DRUG

The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.

Dotilavir sodium tablet

Dotilavir sodium tablet(Tivicay@) DRUG

The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.

Dotilavir sodium tablet(Tivicay@)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

RECRUITING

Central Study Contacts

yu Cao, doctor

CONTACT

86 18661809090; caoyu1767@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 23, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)