Completed

RTVAn Open-label, Randomized Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects

What is being tested

Ritonavir for cycle1 and NORVIR for cycle 2

+ NORVIR for cycle 1 and Ritonavir for cycle 2

Drug

Who is being recruted

From 18 to 45 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: September 2017

See protocol details

Summary

Principal SponsorFirst Affiliated Hospital of Zhejiang University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 23, 2017

Actual date on which the first participant was enrolled.

The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 6 days. During each session, the subjects will be administered a single dose of 100mg Ritonavir (one Ritonavir Tablet 100mg or one NORVIR Tablet 100mg) under fasting or fed condition.

Official TitleAn Open-label, Randomized Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects

NCT03302182

Principal SponsorFirst Affiliated Hospital of Zhejiang University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

96 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate

Healthy adult volunteers of 18-45 years old.

Male (weight ≥50kg);Female (weight ≥45kg)

Body mass index (BMI) between 19~28 kg/m2;

In good health as determined by a physician/investigator based on medical history, vital signs, electrocardiogram (ECG), laboratory tests and physical examination findings at screening;

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18 exclusion criteria prevent from participating

Subject who cannot tolerate venipuncture.

Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;

Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;

Abnormal results of physical examination (hematology, urine test,blood biochemistry etc.), vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) or x-ray with clinical significance.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fed condition. For group3: cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg For group4: cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg

Group II

Experimental

During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fasting condition. For group1: cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg For group2: cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

First affiliated hospital of Zhejiang University

Hangzhou, ChinaOpen First affiliated hospital of Zhejiang University in Google Maps

CompletedOne Study Center