Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects

NCT ID: NCT03302182

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-23
• Study Completion Date: 2017-12-04

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting or fed condition.

Detailed Description

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fasting group

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

Group Type: EXPERIMENTAL

Ritonavir for cycle1 and NORVIR for cycle 2

Intervention Type: DRUG

During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .

NORVIR for cycle 1 and Ritonavir for cycle 2

Intervention Type: DRUG

During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .

Fed group

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 Type: EXPERIMENTAL

Ritonavir for cycle1 and NORVIR for cycle 2

Intervention Type: DRUG

During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .

NORVIR for cycle 1 and Ritonavir for cycle 2

Intervention Type: DRUG

During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .

Interventions

Ritonavir for cycle1 and NORVIR for cycle 2

During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .

Intervention Type: DRUG

NORVIR for cycle 1 and Ritonavir for cycle 2

During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy adult volunteers of 18-45 years old.

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

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

4. 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;

5. Female participant with negative result of HCG test and agrees to use adequate contraception from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;

6. Male participant agrees to use adequate contraception and have no plan to donate sperm from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;

7. Subject who totally understand the aim and progress of this clinical trial, make decision by his/her free will, and signed a consent form to follow the progress;

8. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

Exclusion Criteria

1. Subject who cannot tolerate venipuncture.

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

3. 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;

4. 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.

5. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test;

6. Women who is during lactation, pregnancy or plan to have baby recently.

7. Women with positive result of HCG test.

8. Subject who refuse to use adequate contraception from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;

9. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as alcohol consumption exceeding 14 units per week) within 6 months preceding this study or is unwilling to agree to abstain from alcohol and drugs throughout the study;

10. Heavy smokers (>5 cigarettes per day) within 6 months preceding this study or is unwilling to agree to abstain from smoking throughout the study;

11. Positive test results for alcohol or drug at Screening;

12. History of hospitalization or surgery within 3 months preceding this study.

13. Blood donation within the last 2 months (>= 400 ml), or have a plan to donate blood within 1 month after this study;

14. Intake of any other drug which might influence the results of the trial during two weeks previous to the start of the study.

15. Participation in another study with an investigational drug within the last 3 months preceding this study;

16. History of gastrointestinal surgery, vagotomy, enterotomy or other surgery that may influence gastrointestinal motility,PH or gastrointestinal absorption.

17. Intake of grapefruit or orange (or other food containing grapefruit or orange) 3 days previous to the start of the study. Intake of tea,coffee or other drink containing coffee more than 1L per day.

18. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive Ritonavir.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ZYYY-LTNW-BE-2017-05-2

Identifier Type: -

Identifier Source: org_study_id