CTRI/2024/04/064984招募中Unknown
Single dose Fed 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= 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 subjects. ? - N/A
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:
- •is postmenopausal for at least 1 year
- •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
- •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, Barbiturates a
研究者
相似试验
招募中
Unknown
Bioequivalence study of Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol Tablets 200 mg/300 mg/0.15 mg/0.03 mg in healthy adult female subjects under fasting condition.CTRI/2024/04/064985Mylan Laboratories Limited (A Viatris Company)
尚未招募
1 期
Single-Dose, Fed Bioequivalence Study of MYLAN Rivaroxaban Tablets 20 mg (20 mg; Mylan) and Xarelto® 20 mg (20 mg; Bayer) in Healthy Adult VolunteersBioequivalence Study,Healthy,Thai VolunteersRivaroxaban ,TCTR20201224002International Bio Service Co.,Ltd.36
尚未招募
1 期
Single-Dose, Fed Bioequivalence study of Mylan Esomeprazole 40 mg DR tablets; Mylan Laboratories Limited, India relative to Nexium® 40 mg tablets of AstraZeneca in healthy Thai volunteersBioequivalence studyEsomeprazoleTCTR20200630001Bio-innova and Synchron.Co.,Ltd48
招募中
不适用
Study of absorption and elimination rate of sitagliptin 50 mg tablets in comparison with standard tablets of Sitagliptin (Xelevia®).En In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Sitagliptin 50 mg of test and reference in healthy volunteers..IRCT20200407046981N15Daana pharmaceutical company24
招募中
不适用
Study of absorption and elimination rate of Gabapentin 300 mg capsules in comparison with standard capsules of Gabapentin (NEURONTIN®).In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Gabapentin 300 mg of test and reference in healthy volunteers..IRCT20200407046981N17Daana pharmaceutical company24