An open Label, Two-Treatment, Four-Period, Fully Replicate, Crossover BE Study of TEDAVIR of the GPO, Thailand Comparing co-administration of Reference products (R1) Descovy of Patheon inc., Canada and (R2) tivicay of Glaxo operations uk ltd, united Kingdom in Healthy Subjects under Fasting.
- Conditions
- Healthy male and female subjectsBioequivalence fasting conditions
- Registration Number
- TCTR20220510003
- 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
- 44
a)Non-smoker, normal, healthy, adult, human subjects between 18 and 45 years of age (both inclusive).
b)Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg/height in m2.
c)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).
d)Able to understand and comply with the study procedures, in the opinion of the investigator.
e)Able to give voluntary written informed consent for participation in the study.
f)In case of female subjects:
- Surgically sterilized at least 6 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
a)Known hypersensitivity to Tenofovir alafenamide and emtricitabine or any excipients or any related drug or any substance.
b)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.
c)Ingestion or Use of any medication [prescribed medication & over the counter (OTC) medication including herbal remedies, P-gp inducers (P-glycoprotein) (e.g., rifampicin, rifabutin, carbamazepine) and P-gp inhibitors (e.g., itraconazole, ketoconazole] at any time within 14 days prior to dosing of period I and any vaccine (including COVID-19 vaccine) from 14 days prior to dosing of period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
d)Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
e)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 07 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 IMP administration in period-I.
f)Consumption of grapefruits or grapefruit products within a period of 72 hours prior to IMP administration in period-I.
g)Consumption of xanthine containing food or beverages (tea, coffee, chocolates or cola drinks), tobacco, tobacco containing products (gutkha, pan/pan masala) for 24 hours prior to IMP administration of period-I.
h)CrCl less than or equal to 50 ml/min
i)QTc interval more than 450 msec on ECG measurement at the time of screening.
j)Smokers or who have smoked within last 06 months prior to start of the study.
k)The presence of clinically significant abnormal laboratory values during screening.
l)Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
m)History or presence of seizure or psychiatric disorders.
n)A history of difficulty with donating blood.
o)Difficulty in swallowing oral solid dosage forms like tablets or capsules.
p)Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
q)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.
r)A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
s)A positive test result for HIV (1 &/or 2) antibody.
t)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.
u)Subjects with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
v)Nursing mothers (for female subjects).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 90 % CI pharmacokinetic parameters derived from drug plasma 27 blood sampilng time points (pre-dose (0.000 hour) and at 0.167, 0.333, 0.5, 0.667, 0.833, 1, 1.250, 1.5, 1.75, 2, 2.333, 2.667, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48and 72hours post-dose bioanalysis and pharmacokinetic data analysis
- Secondary Outcome Measures
Name Time Method Adverse event/severe adverse event Vital signs will be measured (Pre-dose on day1, 2, 4, 8, 12, 24, 34, 48 and 72 hrs postdose physical and biochemical examination