An Open Label, Randomized, Two-Period, Two-Sequence, Single Oral Dose, Crossover Bioequivalence Study of ECOXIA (120 mg) of the Government Pharmaceutical Organization, Thailand with ARCOXIA (120 mg) of Frosst Iberica, S.A., Spain in Normal, Healthy, Adult Human Subjects under Fasting Conditions
- Conditions
- Healthy male and female subjectsBioequivalence fed conditions
- Registration Number
- TCTR20211104001
- 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
- 30
a) Non-smokers, normal, healthy, adult, both males and females subjects between 18 and 55 years of age (both inclusive).
b) Having a Body Mass Index (BMI) between 18.0 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 trial.
f) 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
- Urine pregnancy test must be negative.
a) Known hypersensitivity to dolutegravir, lamivudine or tenofovir disoproxil fumarate 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) Subjects who are being or have previously been treated for any GI problems or convulsive, depressive or hepatic disorders, and in whom there is a risk of a recurrence during the study period.
d) Ingestion or use of any medication (prescribed medication & over the counter (OTC) medication including herbal remedies and St. John Wort is 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.
e) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
f) Consumption of grapefruits and grapefruit products within a period of 72 hours prior to dosing in Period-I.
g) Consumption of xanthine containing food or beverages (tea, coffee, chocolates or cola drinks), tobacco, tobacco containing products 24 hours prior to IMP administration of period-I.
h) Smokers or who have smoked within last 06 months prior to start of the study.
i) 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 persent distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing in Period-I.
j) The presence of clinically significant abnormal laboratory values during screening.
k) Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
l) History or presence of seizure or psychiatric disorder. m) A history of difficulty with donating blood.
n) Difficulty in swallowing solids dosage forms like tablets or capsules.
o) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
p) 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.
q) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
r) A positive test result for HIV antibody.
s) A positive test result for COVID-19 RT-PCR test through the nasopharyngeal swab.
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) 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 20 blood sampilng time points (pre-dose (0.000) and 0.167, 0.333, 0.500, 0.750, 1, 1.250, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 48 and 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