Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects

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.

Inclusion criteria

• 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;
• 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;
• 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.

Exclusion criteria

• 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;
• Women who is during lactation, pregnancy or plan to have baby recently.
• Women with positive result of HCG 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.
• Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive Ritonavir.