Bioequivalence Study of Tenofovir Disoproxil Fumarate Tablets in Healthy Chinese Subjects (NCT07558967) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Tenofovir Disoproxil Fumarate Tablets in Healthy Chinese Subjects
China47 participantsStarted 2017-06-20
Plain-language summary
This study evaluated the bioequivalence and safety of the test formulation (Tenofovir Disoproxil Fumarate Tablets, Haisco Pharmaceutical Group Co., Ltd.) and the reference formulation (Viread®, Gilead Sciences, Inc.) in healthy Chinese subjects under fasting and fed conditions
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy male and female subjects aged 18 years or older (including boundary values);
. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) within the range of 19-26 kg/m² (including boundary values), where BMI = weight (kg) / height² (m²);
. Determined to be healthy based on medical history, physical examination, vital signs, and laboratory tests including blood routine, urinalysis, liver and kidney function, blood glucose, and electrocardiogram (ECG) during the screening period. All test results must be within the normal range consistent with age and sex, or meet the protocol requirements, or if outside the normal range, be judged by the investigator as having "no clinical significance (NCS)";
. No recent plans for pregnancy and agreement to use effective non-pharmacological contraceptive measures during the study period and within one month after study completion; Subjects able to communicate well with the investigator, understand and comply with all requirements of this study, and provide written informed consent.
Exclusion criteria
. A history of significant drug or food allergies judged by the investigator to be clinically meaningful, or known allergy to the study drug/class of drugs;
. Regular use of sedatives, hypnotics, or other addictive drugs, or a positive urine drug screen prior to dosing;
. A history of drug abuse, heavy smoking, or alcohol abuse within 12 months prior to dosing;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax
Timeframe: From the start of administration to 72 hours post-dose
2
AUC(0-t) (Area Under the Concentration-Time Curve from time 0 to time t)
Timeframe: From the start of administration to 72 hours post-dose
3
AUC(0-∞) (Area Under the Concentration-Time Curve from time 0 to infinity)
Timeframe: From the start of administration to 72 hours post-dose
. Use of any prescription drugs or Chinese herbal supplements within 4 weeks prior to the first dose of the study drug, and/or use of any over-the-counter (OTC) medications or dietary supplements (including vitamins) within 2 weeks prior to the first dose of the study drug;
. Blood donation or participation in another clinical trial within 3 months prior to enrollment;
. A recent history (within the past 3 years) of autonomic nerve dysfunction and/or current medical history (e.g., recurrent syncope, palpitations, etc.);
. A past medical history of cardiovascular, hepatic, renal, pulmonary, gastrointestinal, or neurological diseases, any condition or illness that may significantly affect drug absorption, distribution, metabolism, or excretion, or any condition or illness that may pose a hazard to the subject participating in the trial. The investigator should consider the following medical history or conditions: history of inflammatory gastrointestinal disease, gastroesophageal reflux, gastrointestinal or rectal bleeding; history of pancreatic injury or pancreatitis; major surgical history such as gastrectomy, gastrointestinal anastomosis, or enterectomy. Clinically significant abnormalities in liver function laboratory tests, such as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin, indicating liver disease or liver injury, or exceeding 1.5 times the upper limit of normal;
. A history or evidence of acute or chronic renal insufficiency, such as serum creatinine above the upper limit of normal (still above the upper limit after repeated testing), clinically significant proteinuria, history of kidney transplantation, etc. A history of severe vomiting or diarrhea within one week prior to the trial;