Clinical trial NCT06592300: Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B in Adults and Paediatric Patients
Lead sponsor: Humanis Saglık Anonim Sirketi
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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:

  i. 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

Exclusion Criteria:

* 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.
* 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).

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 6 hours
measure: AArea under the plasma concentration curve from administration to last observed concentration at time t (AUC0-t)
timeFrame: 6 hours
Secondary outcomes:
measure: Time until Cmax is reached (Tmax)
timeFrame: 6 hours
measure: Area under the plasma concentration curve extrapolated to infinite time (AUC0-∞)
timeFrame: 6 hours
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Lambda Therapeutic Research Ltd.
state: Gujarat
Study officials:
References: