An Open Label, Randomized, Two-Treatment, Four-Period, Two-Sequence, Single Oral Dose, Crossover, Fully Replicate Bioequivalence Study of GPO-Hep C (Sofosbuvir/Velpatasvir 400/100 mg/tablets) of The Government Pharmaceutical Organization, Bangkok, Thailand with EPCLUSA (Sofosbuvir/Velpatasvir 400/100 mg/tablets) of PATHEON INC., Canada in Normal, Healthy, Adult Human Subjects under Fasting Conditions
- Conditions
- Healthy male and female volunteers
- Registration Number
- TCTR20200224005
- Lead Sponsor
- The Government Pharmaceutical Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
i. Non-smokers, normal, healthy, adult, human subjects between 18 and 45 years of age (both
inclusive).
ii. Having a Body Mass Index (BMI) between 18.0 and 30.0 (both inclusive), calculated as weight in
kg/height in m2.
iii. 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
(postero-anterior view).
iv. Able to understand and comply with the study procedures, in the opinion of the investigator.
v. Able to give voluntary written informed consent for participation in the trial.
vi. In case of female subjects:
• Surgically sterilized at least 06 months prior to study participation;
Or
• If of child bearing potential is willing to use a suitable and effective double barrier contraceptive
method or intra uterine device during the study.
And
• Serum pregnancy test must be negative.
Exclusion Criteria
i. Known hypersensitivity to Sofosbuvir and Velpatasvir or any excipients or any related drug or any
substance.
ii. 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.
iii. Ingestion or Use of any medication [prescribed medication & over the counter (OTC) medication
including herbal remedies] at any time in 14 days prior to dosing of period-I. In any such case
subject selection will be at the discretion of the Principal Investigator.
iv. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs
induced urticaria.
v. Consumption of grapefruits and grapefruit products within a period of 72 hours prior to dosing in
Period-I.
vi. Consumption of xanthine containing food or beverages (tea, coffee, chocolates or cola drinks),
tobacco, tobacco containing products (gutkha, pan/pan masala) 24 hours prior to IMP administration
of period-I.
vii. Smokers or who have smoked within last 06 months prior to start of the study
viii. 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 in Period-I.
ix. The presence of clinically significant abnormal laboratory values during screening.
x. Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
xi. History or presence of seizure or psychiatric disorder
xii. A history of difficulty with donating blood.
xiii. Difficulty in swallowing solids dosage forms like tablets or capsules.
xiv. Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study
medication.
xv. 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.
xvi. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
xvii. A positive test result for HIV antibody (1 & 2).
xviii. 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.xix. Nursing mothers (for female subjects).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK parameters derived from drug concentration profile 25 blood sampling timepoints from 0-72 hour post-dose Bioanalysis and pharmacokinetic data analysis
- Secondary Outcome Measures
Name Time Method Adverse events/Severe adverse events Pre-dose and at 01, 03, 06, 09, 12, 24, 36, 48 and 60 hours post-dose Physical and biochemical examination eg. vital signs; blood pressure, pulse rate