HealthyPhase 1NCT07558967
Bioequivalence Study of Tenofovir Disoproxil Fumarate Tablets in Healthy Chinese Subjects
A Phase 1 study testing Test Tenofovir Disoproxil Fumarate Tablets and Reference Tenofovir Disoproxil Fumarate Tablets（Viread®） in people with Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test Tenofovir Disoproxil Fumarate Tablets and Reference Tenofovir Disoproxil Fumarate Tablets（Viread®）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2017to 20 Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- 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.);
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- 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;
- 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);
- Pregnant or lactating women, or women of childbearing age who cannot comply with the required contraceptive measures;
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), syphilis, or HIV antibody;
- Subjects on a special diet, e.g., vegetarians;
- 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;
- 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;
- Any other condition deemed by the investigator as unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Healthy
- Being tested
- Test Tenofovir Disoproxil Fumarate Tablets, Reference Tenofovir Disoproxil Fumarate Tablets（Viread®）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Tenofovir Disoproxil Fumarate TabletsDrug
Test formulation（Tenofovir Disoproxil Fumarate Tablets，Haisco Pharmaceutical Group Co., Ltd），A single oral dose of 300 mg, taken with 240mL of water
Reference Tenofovir Disoproxil Fumarate Tablets（Viread®）Drug
Reference formulation（Viread®，Gilead Sciences, Inc.）A single oral dose of 300 mg, taken with 240mL of water
| Study group | Role | What they receive |
|---|---|---|
| Test formulation (Test Tenofovir Disoproxil Fumarate Tablets) | Experimental | Tenofovir Disoproxil Fumarate Tablets (300 mg/table) Manufacturer: Haisco Pharmaceutical Group Co., Ltd Receives: Drug: Test Tenofovir Disoproxil Fumarate Tablets |
| Reference formulation (Viread®) | Experimental | Tenofovir Disoproxil Fumarate Tablets (Viread®，300 mg/table) Manufacturer: Gilead Sciences, Inc. Receives: Drug: Reference Tenofovir Disoproxil Fumarate Tablets（Viread®） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The maximum blood concentration, the pharmacokinetic parameters of tenofovir in plasma
Measured: 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
Measured: 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
Measured: From the start of administration to 72 hours post-dose
Secondary outcomes (1)
AEs （Adverse events）
The incidence and severity of adverse events
Measured: From the time of signing ICF (Informed Consent Form) to the end of follow-up，up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start20 Jun 2017
- Primary completion23 Aug 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558967
- Sponsor's protocol ID
- HSK-TDF-BE-1.0-161030
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07558967
- Acronym / sponsor ID
- HSK-TDF-BE-1.0-161030
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test formulation (Test Tenofovir Disoproxil Fumarate Tablets) | Experimental | Drug: Test Tenofovir Disoproxil Fumarate TabletsTenofovir Disoproxil Fumarate Tablets (300 mg/table) Manufacturer: Haisco Pharmaceutical Group Co., Ltd |
| Reference formulation (Viread®) | Experimental | Drug: Reference Tenofovir Disoproxil Fumarate Tablets（Viread®）Tenofovir Disoproxil Fumarate Tablets (Viread®，300 mg/table) Manufacturer: Gilead Sciences, Inc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Tenofovir Disoproxil Fumarate TabletsTest formulation（Tenofovir Disoproxil Fumarate Tablets，Haisco Pharmaceutical Group Co., Ltd），A single oral dose of 300 mg, taken with 240mL of water | Drug | Test formulation (Test Tenofovir Disoproxil Fumarate Tablets) |
| Reference Tenofovir Disoproxil Fumarate Tablets（Viread®）Reference formulation（Viread®，Gilead Sciences, Inc.）A single oral dose of 300 mg, taken with 240mL of water | Drug | Reference formulation (Viread®) |
Primary outcome
Cmax
Time frame: From the start of administration to 72 hours post-dose
The maximum blood concentration, the pharmacokinetic parameters of tenofovir in plasma
AUC(0-t) (Area Under the Concentration-Time Curve from time 0 to time t)
Time frame: From the start of administration to 72 hours post-dose
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
AUC(0-∞) (Area Under the Concentration-Time Curve from time 0 to infinity)
Time frame: From the start of administration to 72 hours post-dose
The area under the blood concentration-time curve from 0 to infinite time (∞), the pharmacokinetic parameters of tenofovir in plasma
1 secondary outcome
AEs （Adverse events）
Time frame: From the time of signing ICF (Informed Consent Form) to the end of follow-up，up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test Tenofovir Disoproxil Fumarate Tablets and Reference Tenofovir Disoproxil Fumarate Tablets（Viread®） in people with Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: From the start of administration to 72 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.