Chronic Hepatitis B in Adults and Paediatric PatientsPhase 1NCT06592300
Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects
A Phase 1 study testing Tenofovir Alafenamide Film coated Tablet and Vemlidy® film-coated tablets in people with Chronic Hepatitis B in Adults and Paediatric Patients, run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial summary
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose, fully replicate, bioequivalence study in normal, healthy, adult, human subjects under fed condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B in Adults and Paediatric Patients
- What is being tested?
- Tenofovir Alafenamide Film coated Tablet and Vemlidy® film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndia
- Study dates
- 6 Jul 2024to 13 Sep 2024
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker, Normal, healthy, adult, human, subjects between 18 and 45 years of age (both inclusive).
- Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kg/height in m2.
- Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings (P/A view).
- Able to understand and comply with the study procedures, in the opinion of the investigator.
- Able to give voluntary written informed consent for participation in the trial.
- In case of female subjects:
- Surgically sterilized at least 6 months prior to study participation. Or If of child bearing potential 1s willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- And ii. Serum pregnancy test must be negative
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to Tenofovir alafenamide or any of the excipients or any related drug.
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion or Use of medication [prescribed \& over the counter (OTC) medication including but not limited to herbal medicines, Oxcarbazepine ,Phenobarbital, Phenytoin, Itraconazole, Ketoconazole ,Rifampicin ,Rifapentine, Rifabutin, Tipranavir/ritonavir)] at any time from 14 days prior to dosing of period-I and any vaccine (including COVID-19 vaccine) within 14 days prior to dosing of period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- Consumption of grap_efruits or its products within a period of 72 hours prior to dosing of period-I.
- Smokers or who have smoked within last 06 months prior to start of the study.
Show all 20Show fewer
- A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing of period-I.
- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- History or presence of seizure or psychiatric disorder.
- A history of difficulty with donating blood.
- Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication**.
- If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
- Difficulty in swallowing oral solid dosage form like capsule or tablet.
- A positive hepatitis screen including hepatitis B surface antigen and/or HCV ntibodies.
- A positive test result for HIV antibody (1 \&/or 2).
- An unusual diet, for whatever reason (for example, fasting, high potassium or low sodium), for four weeks prior to receiving the study drug in period I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Subject with rare Hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption.
- Nursing mothers (for female subjects).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Two-sequence, Two-treatment, Four -Period, Single Oral Dose, Fully Replicate,Bioequivalence Study in Normal, Healthy, Adult, Human Subjects Under Fed Condition.
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose, fully replicate, bioequivalence study in normal, healthy, adult, human subjects under fed condition.
- Being tested
- Tenofovir Alafenamide Film coated Tablet, Vemlidy® film-coated tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Alafenamide Film coated TabletDrug
The administration was performed in the morning, 30 minutes after a high-fat, high-calorie vegetarian breakfast was served following an overnight fast of at least 10 hours.
Vemlidy® film-coated tabletsDrug
The administration was performed in the morning, 30 minutes after a high-fat, high-calorie vegetarian breakfast was served following an overnight fast of at least 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir Alafenamide Film Tablet | Experimental | Tenofovir Alafenamide 25 mg Film Tablet Receives: Drug: Tenofovir Alafenamide Film coated Tablet; Drug: Vemlidy® film-coated tablets |
| Vemlidy® film-coated tablets | Active comparator | Vemlidy® 25 mg film-coated tablets Receives: Drug: Tenofovir Alafenamide Film coated Tablet; Drug: Vemlidy® film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
If the reference product intra-subject CV is less than or equal to 30% for Cmax, then the 90% confidence interval of the relative mean Cmax of the test to reference formulation for Ln-transformed data was to be within 80.00% to 125.00%.
Measured: 6 hours
AArea under the plasma concentration curve from administration to last observed concentration at time t (AUC0-t)
The 90% confidence interval of the relative mean (Geometric mean) of the Test to reference formulation for Ln-transformed AUCt was to be within 80.00% to 125.00%
Measured: 6 hours
Secondary outcomes (2)
Time until Cmax is reached (Tmax)
Descriptive Statistics
Measured: 6 hours
Area under the plasma concentration curve extrapolated to infinite time (AUC0-∞)
Descriptive Statistics
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Jul 2024
- Primary completion2 Aug 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B in Adults and Paediatric PatientsStudies of the same condition, open and under way.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592300
- Sponsor's protocol ID
- 0030-24
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 18 Apr 2025
- 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-sequence, Two-treatment, Four -Period, Single Oral Dose, Fully Replicate,Bioequivalence Study in Normal, Healthy, Adult, Human Subjects Under Fed Condition.
- ClinicalTrials.gov ID
- NCT06592300
- Acronym / sponsor ID
- 0030-24
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2024 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 19 Sep 2024 (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.
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose, fully replicate, bioequivalence study in normal, healthy, adult, human subjects under fed condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir Alafenamide Film Tablet | Experimental | Drug: Tenofovir Alafenamide Film coated Tablet, Drug: Vemlidy® film-coated tabletsTenofovir Alafenamide 25 mg Film Tablet |
| Vemlidy® film-coated tablets | Active comparator | Drug: Tenofovir Alafenamide Film coated Tablet, Drug: Vemlidy® film-coated tabletsVemlidy® 25 mg film-coated tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Non-smoker, Normal, healthy, adult, human, subjects between 18 and 45 years of age (both inclusive).
- Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kg/height in m2.
- Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings (P/A view).
- Able to understand and comply with the study procedures, in the opinion of the investigator.
- Able to give voluntary written informed consent for participation in the trial.
Key exclusion criteria (20 listed)
- Known hypersensitivity or idiosyncratic reaction to Tenofovir alafenamide or any of the excipients or any related drug.
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion or Use of medication [prescribed \& over the counter (OTC) medication including but not limited to herbal medicines, Oxcarbazepine ,Phenobarbital, Phenytoin, Itraconazole, Ketoconazole ,Rifampicin ,Rifapentine, Rifabutin, Tipranavir/ritonavir)] at any time from 14 days prior to dosing of period-I and any vaccine (including COVID-19 vaccine) within 14 days prior to dosing of period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- Consumption of grap_efruits or its products within a period of 72 hours prior to dosing of period-I.
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 |
|---|---|---|
| Tenofovir Alafenamide Film coated TabletThe administration was performed in the morning, 30 minutes after a high-fat, high-calorie vegetarian breakfast was served following an overnight fast of at least 10 hours. | Drug | Tenofovir Alafenamide Film Tablet, Vemlidy® film-coated tablets |
| Vemlidy® film-coated tabletsThe administration was performed in the morning, 30 minutes after a high-fat, high-calorie vegetarian breakfast was served following an overnight fast of at least 10 hours. | Drug | Tenofovir Alafenamide Film Tablet, Vemlidy® film-coated tablets |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: 6 hours
If the reference product intra-subject CV is less than or equal to 30% for Cmax, then the 90% confidence interval of the relative mean Cmax of the test to reference formulation for Ln-transformed data was to be within 80.00% to 125.00%.
AArea under the plasma concentration curve from administration to last observed concentration at time t (AUC0-t)
Time frame: 6 hours
The 90% confidence interval of the relative mean (Geometric mean) of the Test to reference formulation for Ln-transformed AUCt was to be within 80.00% to 125.00%
2 secondary outcomes
Time until Cmax is reached (Tmax)
Time frame: 6 hours
Area under the plasma concentration curve extrapolated to infinite time (AUC0-∞)
Time frame: 6 hours
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 18 Apr 2025.
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 Tenofovir Alafenamide Film coated Tablet and Vemlidy® film-coated tablets in people with Chronic Hepatitis B in Adults and Paediatric Patients, run by Humanis Saglık Anonim Sirketi at 1 site in India.
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 8 inclusion and 20 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 18 Apr 2025. 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 India. 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?
Maximum plasma concentration (Cmax) (time frame: 6 hours). The study lists 2 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 18 Apr 2025.