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

NCT ID: NCT05168176

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-01-31

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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Dotilavir sodium tablet

Group Type EXPERIMENTAL

Dotilavir sodium tablet

Intervention Type DRUG

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

Dotilavir sodium tablet(Tivicay@)

Group Type ACTIVE_COMPARATOR

Dotilavir sodium tablet(Tivicay@)

Intervention Type DRUG

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

Interventions

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Dotilavir sodium tablet

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

Intervention Type DRUG

Dotilavir sodium tablet(Tivicay@)

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

Intervention Type DRUG

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yu Cao, doctor

Role: CONTACT

Phone: 86 18661809090

Email: [email protected]

Facility Contacts

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Yu Cao, Doctor

Role: primary

Other Identifiers

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QL-YK1-045-001

Identifier Type: -

Identifier Source: org_study_id