Healthy male and female subjects Healthy male and female subjects Bioequivalence fed conditions
Conditions
Interventions
LAMIGRASE is a combination tablet containing Dolutegravir (50 mg) and Lamivudine (300 mg), manufactured by the Government Pharmaceutical Organization (GPO), Thailand. The intervention is administered
Experimental Drug,Active Comparator Drug
LAMIGRASE (Dolutegravir/Lamivudine 50 mg/300 mg tablets),Dovato (Dolutegravir/Lamivudine 50 mg/300 mg tablets)
Sponsors
The Government Pharmaceutical Organization
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Normal, healthy, adult, both males and females subjects between 18 and 55 years of age (both inclusive). 2) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg/height in m2. 3) Subject whose clinical laboratory values are within normal/acceptable reference ranges or clinically insignificant during screening as determined by physician or principal investigator to be of no clinical significance. If any subject has values outside of the pre-defined normal/acceptable range, the study physician/ Principal Investigator should have a clearly documented and medically rigorous justification for making that exception. 4) Subject whose medical history, clinical examination, 12 lead ECG, and chest X-ray recordings (postero-anterior view) are normal or clinically insignificant during screening as determined by physician or principal investigator to be of no clinical significance. 5) Able to understand and comply with the study procedures, in the opinion of the investigator. 6) Able to give voluntary written informed consent for participation in the trial. 7) 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.
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to dolutegravir, lamivudine or any excipients or any related drug orany substance. 2) 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. 3) 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 studyperiod. 4) Ingestion or use of any medication prescribed or OTC including herbal remedies and St John Worts within 14 days prior to dosing in Period I subject selection at the discretion of the Principal Investigator 5) Any history of bronchospasm, asthma, urticaria or other allergic type reactions after takingany medication. 6) Consumption of grapefruits and grapefruit products within a period of 72 hours prior todosing in Period-I. 7) Consumption of xanthine containing food or beverages (tea, coffee, chocolates or coladrinks) 24 hours prior to IMP administration of period-I. 8) Heavy smoking 10 or more cigarettes per day 9) Moderate smoking (< 10 cigarettes/day) and consumption of tobacco containing products, whichcannot stop smoking or consuming 24 hours prior to dosing and for entire duration of the study. 10) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption ofmore than 14 standard drinks per week for men and more than 7 standard drinks per weekfor women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of40% distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol oralcoholic products within 48 hours prior to dosing in Period-I. 11) The presence of clinically significant abnormal laboratory values during screening. 12) Use of any recreational drugs or history of drug addiction or testing positive in pre study drugscans. 13) History or presence of seizure or psychiatric disorder. 14) A history of difficulty with donating blood. 15) Difficulty in swallowing solids dosage forms like tablets or capsules. 16) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose ofstudy medication. 17) 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. 18) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. 19) A positive test result for HIV antibody (1 &/or 2). 20) A positive test result for COVID-19 RT-PCR test through the nasopharyngeal swab. 21) 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 selectionwill be at the discretion of the Principal Investigator.22) Nursing mothers (for female subjects).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence between LAMIGRASE and Dovato in terms of pharmacokinetic parameters. Pharmacokinetic measurements are taken at pre-dose and 25 time points post-dose, up to 72 hours. Pharmacokinetic parameters AUC Cmax Tmax measured using LCMSMS to assess bioequivalence between LAMIGRASE and Dovato. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of LAMIGRASE compared to Dovato. Assessed at screening pre-dose post-dose and at study completion Incidence of adverse events physical examinations vital signs clinical laboratory tests and 12-lead ECG,Safety and tolerability of LAMIGRASE compared to Dovato. Assessed at screening pre-dose post-dose and at study completion. Incidence of adverse events physical examinations vital signs clinical laboratory tests and 12-lead ECG. | — |
Countries
Thailand
Contacts
Public ContactDr. Porranee Puranajoti
International Bio Service Co.,Ltd.
Outcome results
None listed