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 fulfil 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 any clinical research study or blood donations till 90 days after the study completion. 9. Willing to avoid or take parecautions while performing the skilled tasks like driving, operating machinery, while working at high elevations etc., but not limited to. 10. Subject able to communicate effectively and provide written informed consent. 11. Subject willing to adhere to protocol requirements as evidenced by written informed consent approved by an Independent Ethics Committee (IEC). 12. Male subjects willing to follow acceptable barrier method of contraception during the study and till 07 days after completion of the study. 13. If study subject is a female and is of childbearing potential practicing an acceptable method of birth control for the duration of the study and till 07 days after completion 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/capsules 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 (greeter than) 129/79 millimeters of mercury (Systolic blood pressure/Diastolic blood pressure). Pulse rate less than 60 beats / minute and more than 100 beats /minute. 10.Any history or presence of fractures or decreases in bone density. 11. Any history/evidence of Lactic acidosis and severe hepatomegaly. 12. 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. 13. A depot injection or implant of any drug within 3 months prior to initial administration of study medication. 14. 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) 1.5 times the upper limit of normal. 16. Any clinically significant illness during 3 months before screening. 17.Participation in a drug research study/donation of blood within past 90 days. 18. Amenorrhea or irregular menstrual periods (defined unable to predict within 7 days) during past 6 months for females. 19.Female subject who is currently breast feeding or a female study subject who is pregnant or who may wish to become pregnant during the study. 20. Female subject demonstrating positive for pregnancy test (performed at the time of each period check-in). 21. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug. 22. 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/period as per PI discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of this study is to investigate the comparative relative oral bioavailability of Mylan s Test product Emtricitabine, Tenofovir Alafenamide and Dolutegravir 15 mg/1.88 mg/5 mg Tablets for OralSuspension with Reference product (R=R1+R2) R1: TIVICAY PD (Dolutegravir) 5 mg Tablets for oral suspension of ViiV healthcare, Durham, NC 27701 and R2: DESCOVY (emtricitabine and tenofovir alafenamide) 15 mg and 1.88 mg Tablets for oral suspension of Gilead Sciences, Inc. Foster City, CA 94404 following a single oral dose of test product or reference products administration under Fed conditionsTimepoint: 2 Months clinical schedule | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events & to ensure the safety of the subjects.Timepoint: at baseline, 4 weeks & 8 weeks | — |
Countries
India
Contacts
Public ContactDr Nikhil Kumar Kursam MBBS MD
Aizant Drug Research Solutions Pvt. Ltd.
Outcome results
None listed