Bioequivalence Study (Preliminary Study) of Ritonavir Versus NORVIR in Healthy Chinese Subjects

NCT03214159 | Completed Phase 1

• 1 other identifier: ZYYY-LTNW-BE-2017-05
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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 condition.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (4)

• Cmax: Maximum Observed Plasma Concentration for ritonavir

  Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

  36 hours post-dose on Day 1,7,13 and 19

• Tmax

  Time to Reach the Maximum Plasma Concentration

  36 hours post-dose on Day 1,7,13 and 19

• AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir

  AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity

  Time Frame: 36 hours post-dose on Day 1,7,13 and 19

• AUC(0-36h): Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir

  AUC(0-36h) is measure of area under the plasma concentration and time curve from Time 0 to 36 hours postdose.

  36 hours post-dose on Day 1,7,13 and 19

Study Arms (2)

group 1

EXPERIMENTAL

During the study session, healthy subjects will be administered a single dose of Ritonavir or Tablet 100mg or NORVIR tablet 100mg under fasting condition. Intervention: cylcle 1 Drug: Ritonavir tablet 100mg cylcle 2 Drug: NORVIR tablet 100mg cylcle 3 Drug: Ritonavir tablet 100mg cylcle 4 Drug: NORVIR tablet 100mg

Drug: Ritonavir Tablet 100mg; Drug: NORVIR tablet 100mg

group 2

EXPERIMENTAL

During the study session, healthy subjects will be administered a single dose of Ritonavir or Tablet 100mg or NORVIR tablet 100mg under fasting condition. Intervention: cylcle 1 Drug: NORVIR tablet 100mg cylcle 2 Drug: Ritonavir tablet 100mg cylcle 3 Drug: NORVIR tablet 100mg cylcle 4 Drug: Ritonavir tablet 100mg

Drug: Ritonavir Tablet 100mg; Drug: NORVIR tablet 100mg

Interventions

Ritonavir Tablet 100mg DRUG

Ritonavir Tablet 100mg is a generic product manufactured by Ascletis Pharmaceutical Co., Ltd.

group 1; group 2

NORVIR tablet 100mg DRUG

NORVIR Tablet is a generic product manufactured by AbbVie. NORVIR Tablet 100mg will be used as a comparator drug for the BE study.

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers of 18-45 years old.
• Male (weight ≥50kg)
• 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;
• 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;
• 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;
• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

You may not qualify if:

• 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.
• 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;
• 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;
• 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;
• Heavy smokers (\>5 cigarettes per day) within 6 months preceding this study or is unwilling to agree to abstain from smoking throughout the study;
• Positive test results for alcohol or drug at Screening;
• History of hospitalization or surgery within 3 months preceding this study.
• Blood donation within the last 2 months (\>= 400 ml), or have a plan to donate blood within 1 month after this study;
• Intake of any other drug which might influence the results of the trial during two weeks previous to the start of the study.
• Participation in another study with an investigational drug within the last 3 months preceding this study;
• History of gastrointestinal surgery, vagotomy, enterotomy or other surgery that may influence gastrointestinal motility,PH or gastrointestinal absorption.
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Ascletis Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

First affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

First affiliated hospital of Zhejiang University

Hanzhou, Zhejiang, 310003, China

Location

MeSH Terms

Interventions

Ritonavir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: July 9, 2017
• First Posted: July 11, 2017
• Study Start: July 11, 2017
• Primary Completion: August 31, 2017
• Study Completion: September 20, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)