None listed
Conditions
Interventions
Intervention1: Emtricitabine, Tenofovir Alafenamide and Dolutegravir 15 mg/1.88 mg/5 mg Tablets for Oral Suspension: Single dose Fed oral bioequivalence study of Emtricitabine, Tenofovir Alafenamide a
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must fulfill all of the following criteria to be considered for inclusion into this study. 1. Normal healthy adult males and non-pregnant, non-lactating females, age between 18 to 45 years (inclusive of both). 2. Body mass index of (greater than or equal to) 18.5 kg/m2 and (less than and equal to) 30.0 kg/m2 and weight (greater than or equal to) 50.00 kg. 3. Healthy according to the laboratory results and physical examination, performed within 21 days prior to the commencement of the dosing in Period-1. 4. Subject whose clinical laboratory values are within normal limits or clinically insignificant as determined by physician or principal investigator to be of no clinical significance. 5. Have normal ECG, Chest X-ray and vital signs. 6. Non-smoker and Non-alcoholic. 7. Subject creatinine clearance (CrCl) should be more than 60 mL/min. 8. Willing to not to participate in clinical research study or blood donations till 90 days after the study completion. 9. Subject able to communicate effectively and provide written informed consent. 10. Subject willing to adhere to protocol requirements as evidenced by written informed consent approved by an Independent Ethics Committee (IEC). 11. If study subject is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence. Or is postmenopausal for at least 1 year Or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy or tubectomy has been performed on the study subject).
Exclusion criteria
Exclusion criteria: Subject candidates must not be enrolled in the study if they meet any of the following criteria. 1. Any history of allergy or hypersensitivity to Emtricitabine, Tenofovir Alafenamide and Dolutegravir or other related drugs. 2. Positive test result for hepatitis B surface antigen (HBs Ag), hepatitis C virus antibody (HCV Ab) or HIV-1 antibody or HIV Type 2 (HIV-2) antibody (HIV Ab) and VDRL / syphilis. 3. The study drug is contraindicated for medical reasons. 4. Any history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, dermatological, neurological, psychiatric diseases or disorders. 5. History or presence of drug abuse in the past one year. 6. Difficulty in swallowing tablets or suspension. 7. Any history of difficulty in donating blood. 8. Had clinically significant abnormal values of laboratory parameters. 9. Blood pressure is (less than) 90/60 and (greater than) 129/79 millimeters of mercury (Systolic blood pressure/ Diastolic blood pressure). 10. Pulse rate less than 60 beats / minute and more than 100 beats / minute. 11. Any history or presence of fractures or decreases in bone density. 12. Any history evidence of Lactic acidosis and severe hepatomegaly. 13. Use of any prescription or over the counter (OTC) medications other than hormonal contraceptive or hormone replacement therapy within the 14 days prior to the initial administration of study medication. 14. A depot injection or implant of any drug within 3 months prior to initial administration of study medication. 15. Use of any medication, herbal supplement, or vitamin known to induce or inhibit hepatic enzyme activity within 28 days prior to the initial administration of study medication. 15. Liver function tests (ALT, AST and bilirubin) 1.1 times the upper limit of normal. 16. Amenorrhea or irregular menstrual periods (defined unable to predict within 7 days) during past 6 months for females. 17. Female subject who is currently breast feeding or a female study subject who is pregnant or who is likely to become pregnant during the study. 18. Female subject demonstrating positive for pregnancy test (performed at the time of each period check-in). 19. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug. 20. Subject positive for urine or breath alcohol test, urine screen for drugs of abuse [Cannabinoids (Marijuana / Tetra Hydro Cannabinoids-THC), Cocaine, Opiates (morphine), Amphetamine, Barbiturates and Benzodiazepines] at the time of each period check-in will be excluded from the study. 21. Any clinically significant illness during 3 months before screening. 22. Participation in a drug research study/donation of blood within past 90 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax and AUC0-tTimepoint: For Period 01 & 02: 0.00, 0.083, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00 and 72.00 hours. For Period 03 & 04: 0.00, 0.083, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the subjectsTimepoint: 45 days clinical schedule | — |
Countries
India
Contacts
Public ContactAnjum Jabeen MBBS MD
Aizant Drug Research Solutions Pvt. Ltd.,
Outcome results
None listed