CTRI/2024/04/064985招募中Unknown
Single dose Fasting oral bioequivalence study of 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 Ethinyl estradiol Tablets USP), 0.15 mg /0.03 mg Distributed by- Mayne Pharma Greenville, NC 27834 in healthy adult female subjects - ETLE
Mylan Laboratories Limited (A Viatris Company)0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 ? 18.5 kg/m2
- •and ? 30.0 kg/m2
- •and weight ? 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).
排除标准
- •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
- •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 <50ml/min
- •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 < 100/60 and > 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,
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