Bioequivalence Study of Tenofovir Disoproxil Fumarate Tablets in Healthy Chinese Subjects

Bioequivalence and Safety Study of Tenofovir Disoproxil Fumarate Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions: a Randomized, Open-label, Single-dose, Crossover Study

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Test Tenofovir Disoproxil Fumarate Tablets; Drug: Reference Tenofovir Disoproxil Fumarate Tablets（Viread®）

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shenyang, China
    • General Hospital of Shenyang Military Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male and female subjects aged 18 years or older (including boundary values);
2. 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);
3. 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)";
4. 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:

1. 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;
2. Regular use of sedatives, hypnotics, or other addictive drugs, or a positive urine drug screen prior to dosing;
3. A history of drug abuse, heavy smoking, or alcohol abuse within 12 months prior to dosing;
4. 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;
5. Blood donation or participation in another clinical trial within 3 months prior to enrollment;
6. A recent history (within the past 3 years) of autonomic nerve dysfunction and/or current medical history (e.g., recurrent syncope, palpitations, etc.);
7. 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;
8. 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;
9. Subjects with an estimated endogenous creatinine clearance rate (calculated from serum creatinine levels during the screening period) below 80 mL/min (formula for endogenous creatinine clearance rate: Ccr = (140 - age) × body weight (kg) / [72 × Scr (mg/dL)] or Ccr = [(140 - age) × body weight (kg)] / [0.818 × Scr (μmol/L)]. Note the units of serum creatinine in the calculation; for female subjects, multiply the result by 0.85);
10. Pregnant or lactating women, or women of childbearing age who cannot comply with the required contraceptive measures;
11. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), syphilis, or HIV antibody;
12. Subjects on a special diet, e.g., vegetarians;
13. Subjects who refuse to abstain from any beverages or foods containing methylxanthines, such as caffeine (coffee, tea, cola, chocolate, etc.), from 48 hours before the start of the trial until the end of the trial;
14. Subjects who refuse to abstain from any beverages or foods containing grapefruit from 7 days before the start of the trial until the end of the trial;
15. Any other condition deemed by the investigator as unsuitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test formulation (Test Tenofovir Disoproxil Fumarate Tablets); Tenofovir Disoproxil Fumarate Tablets (300 mg/table) Manufacturer: Haisco Pharmaceutical Group Co., Ltd	Drug: Test Tenofovir Disoproxil Fumarate Tablets; Test formulation（Tenofovir Disoproxil Fumarate Tablets，Haisco Pharmaceutical Group Co., Ltd），A single oral dose of 300 mg, taken with 240mL of water
Experimental: Reference formulation (Viread®); Tenofovir Disoproxil Fumarate Tablets (Viread®，300 mg/table) Manufacturer: Gilead Sciences, Inc.	Drug: Reference Tenofovir Disoproxil Fumarate Tablets（Viread®）; Reference formulation（Viread®，Gilead Sciences, Inc.）A single oral dose of 300 mg, taken with 240mL of water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	The maximum blood concentration, the pharmacokinetic parameters of tenofovir in plasma	From the start of administration to 72 hours post-dose
AUC(0-t) (Area Under the Concentration-Time Curve from time 0 to time t)	The area under the blood concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t was measured, the pharmacokinetic parameters of tenofovir in plasma	From the start of administration to 72 hours post-dose
AUC(0-∞) (Area Under the Concentration-Time Curve from time 0 to infinity)	The area under the blood concentration-time curve from 0 to infinite time (∞), the pharmacokinetic parameters of tenofovir in plasma	From the start of administration to 72 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs （Adverse events）	The incidence and severity of adverse events	From the time of signing ICF (Informed Consent Form) to the end of follow-up，up to 10 days

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): August 23, 2017
• Study Completion (Actual): November 20, 2017

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 26, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HSK-TDF-BE-1.0-161030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No