None listed
Conditions
Interventions
Intervention1: Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl
Estradiol Tablets, 200 mg/300 mg/0.15 mg/0.03 mg: single-dose, randomized, balanced,
two-period, two-sequence,
Sponsors
Mylan Laboratories Limited (A Viatris Company)
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 female subjects, age between 18 to 45 years. 2. Body mass index of ï?³ 18.5 kg/m2 and ï?£ 30.0 kg/m2 and weight ï?³ 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. Willing to not to participate in clinical research study or blood donations till 90 days after the study completion. 8. Subject able to communicate effectively and provide written informed consent. 9. Subject willing to adhere to protocol requirements as evidenced by written informed consent approved by an Independent Ethics Committee (IEC). 10. 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 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 Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol 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). 3. The study drug is contraindicated for medical reasons. 4. Amenorrhea or irregular menstrual periods (defined unable to predict within 7 days) during past 6 months for females. 5. Any history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, dermatological, neurological, psychiatric diseases or disorders. 6. History or presence of drug abuse in the past one year. 7. Difficulty in swallowing tablets. 8. Any history of difficulty in donating blood. 9. Had clinically significant abnormal values of laboratory parameters. 10. History of pathologic fracture or other risk factors for osteoporosis or bone loss. 11. Subjects with Creatinine clearance 12. Any past medical history or family history of thrombotic or thromboembolic disorder 13. History suggests an inherited or acquired hypercoagulopathy 14. History of cholestasis,pancreatitis and other gall bladder disorders. 15. History or presence of migraine headache with or without aura. 16. History of amenorrhoea, oligomenorrhoea and irregular menstruation. 17. History of Hereditary Angioedema and a history of chloasma gravidarum. 18. Subject having Modified Patient Health Questionnaire (MPHQ) -12 questionnaires >4 in each period check-in. 19. Blood pressure is 129/79 millimeters of mercury (Systolic blood pressure/ Diastolic blood pressure). 20. Pulse rate less than 60 beats / minute and more than 100 beats / minute. 21. 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. 22. Use of depot injection or implant of any drug other than hormonal contraceptive or hormone replacement therapy within 3 months prior to initial administration of study medication. 23. 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. 24. Any clinically significant illness during 3 months before screening. 25. Participation in a drug research study/donation of blood within past 90 days. 26. 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. 27. Female subject demonstrating positive for pregnancy test (performed at the time of each period check-in). 28. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug. Subject positive for urine alcohol test, urine screen for drugs of abuse [Cannabinoids (Marijuana / Tetra Hydro Cannabinoids-THC), Cocaine, Opiates (morphine), Amphetamine,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of this study is to investigate the bioequivalence of Test product (T) Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol Tablets 200 mg/300 mg/0.15 mg/0.03 mg of Mylan Laboratories Limited, India with Reference product (R equal to R1 + R2) R1- Truvada® (emtricitabine and tenofovir disoproxil fumarate) tablets 200 mg / 300 mg Manufactured for- Gilead Sciences Inc, Foster City, CA 94404, Made in Germany and R2- Levora® 0.15/30-28 (Levonorgestrel and Ethinylestradiol Tablets USP), 0.15 mg /0.03 mg Distributed by: Mayne Pharma Greenville, NC 27834 in healthy adult female subjectsTimepoint: In each study period, Six milliliter (1 Ã? 6 mL) blood samples (26) will be collected in K2EDTA Vacutainers at pre-dose (0.00) and the following times after dosing 0.167, 0.33, 0.50, 0.67, 0.83, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the subjects under fasting conditions. Timepoint: In each study period, Six milliliter (1 Ã? 6 mL) blood samples (26) will be collected in K2EDTA Vacutainers at pre-dose (0.00) and the following times after dosing 0.167, 0.33, 0.50, 0.67, 0.83, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours | — |
Countries
India
Contacts
Public ContactDr Ramana Reddy Nalla MBBS
Aizant Drug Research Solutions Pvt Ltd
Outcome results
None listed