Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Hepatitis B in Adults and Paediatric Patients

Outcome Measures

Primary Outcomes (2)

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%.
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%
6 hours

Secondary Outcomes (2)

Time until Cmax is reached (Tmax)
6 hours
Area under the plasma concentration curve extrapolated to infinite time (AUC0-∞)
6 hours

Study Arms (2)

Tenofovir Alafenamide Film Tablet

EXPERIMENTAL

Tenofovir Alafenamide 25 mg Film Tablet

Drug: Tenofovir Alafenamide Film coated TabletDrug: Vemlidy® film-coated tablets

Vemlidy® film-coated tablets

ACTIVE COMPARATOR

Vemlidy® 25 mg film-coated tablets

Drug: Tenofovir Alafenamide Film coated TabletDrug: Vemlidy® film-coated tablets

Interventions

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.

Tenofovir Alafenamide Film TabletVemlidy® film-coated tablets

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.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Humanis Saglık Anonim Sirketi
Industrylead

Study Sites (1)

Lambda Therapeutic Research Ltd.

Ahmedabad, Gujarat, 382481, India

MeSH Terms

Interventions

tenofovir alafenamide

Enrollment

42 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

July 6, 2024

Actual (reported)

You may not qualify if:

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.
+5 more criteria

Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

Tenofovir Alafenamide Film Tablet

Vemlidy® film-coated tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

Tenofovir Alafenamide Film Tablet

Vemlidy® film-coated tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations