NL-OMON48510已完成不适用
A Randomized, Double-blind, 2-Way Crossover Bioequivalence and Adhesion Study of a Transdermal Contraceptive Patch Manufactured with Newly Sourced Adhesive Components at the End of Shelf Life and Currently Marketed EVRA® at the Beginning of Shelf Life in Healthy Adult Women - Bioequivalence and adhesion study of EVRA patches
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject must be a woman of childbearing potential 18 to 45 years of age,
- •inclusive, at screening
- •2. Subject has a body mass index (BMI) between 18 and 30 kg/m², inclusive, and
- •body weight not less than 50 kg and not more than 100 kg at screening.
- •3. Subject must be healthy on the basis of physical examination, medical
- •history, vital signs, and 12-lead electrocardiogram (ECG) performed at
- •screening. This determination will be recorded in the source documents and
- •signed by the investigator.
- •4. Subject must have a negative serum (Beta-human chorionic gonadotropin
- •[Beta-hCG]) pregnancy test at screening and a negative urine pregnancy test on
- •Day -1 of each treatment period.
- •5. Subject must be willing and able to adhere to the prohibitions and
- •restrictions specified in this protocol (see Section 4.4, Prohibitions and
- •Restrictions).
- •6. Subject must be surgically sterile with intact ovaries, sexually abstinent,
- •or, if sexually active with a non-sterilized male partner, be using a highly
- •effective method (ie, failure rate of <1% per year) of nonhormonal
- •contraception (eg, intrauterine device [IUD]) before admission until 1 month
- •after completion of the study.
- •7. Subject must agree not to donate eggs (ova, oocytes) for the purposes of
- •assisted reproduction during the study or within 1 month after completion of
- •8. Each subject must sign an ICF indicating that she understands the purpose
- •of, and procedures required for, the study, and is willing to participate in
- •9. Subject has a blood pressure (measured in supine position, after at least 5
- •minutes rest in supine position) between 90 and 140 mmHg systolic, inclusive,
- •and no higher than 90 mmHg diastolic at screening.
- •10. Subject has hematocrit of at least 36% at screening.
- •11. Subject must have a 12-lead ECG consistent with normal cardiac conduction
- •and function at screening, including:
- •Normal sinus rhythm with heart rate between 45 and 100 beats per minute (bpm),
- •extremes included. QT interval corrected for heart rate (QTc) according to
- •Fridericia's formula (QTcF)7 <=470 ms. QRS interval <=120 ms. PR interval <=220
- •ms. ECG morphology consistent with healthy cardiac conduction and function. Any
- •evidence of heart block and left or right bundle branch block is exclusionary.
- •12. Subject must be a non-smoker, or an ex-smoker for >6 months, must not use
- •nicotine-containing substances including tobacco products (eg, cigarettes,
- •e-cigarettes, cigars, chewing tobacco, gum, patch), and tests negative for
- •cotinine at screening and on Day -1 of each treatment period.
排除标准
- •1. Subject has a history of or current clinically significant medical illness
- •including (but not limited to) cardiac arrhythmias or other cardiac disease,
- •hematologic disease, coagulation disorders (including any abnormal bleeding or
- •blood dyscrasias), lipid abnormalities, significant pulmonary disease,
- •including bronchospastic respiratory disease, diabetes mellitus, renal or
- •hepatic insufficiency, thyroid disease, neurologic or psychiatric disease,
- •infection, cholelithiasis (gall stone disease), chronic idiopathic jaundice,
- •family history of cholestatic jaundice, or any other illness that the
- •investigator considers should exclude the subject or that could interfere with
- •the interpretation of the study results.
- •2. Subject has clinically significant abnormal values for hematology,
- •biochemistry, or urinalysis at screening as deemed appropriate by the
- •investigator.
- •3. Subject has abnormal thyroid stimulating hormone level at screening.
- •4. Subject has clinically significant abnormal 12-lead ECG, vital signs, or
- •physical examination at screening as deemed appropriate by the investigator.
- •5. Subject has a history or presence of disorders commonly accepted as
- •contraindications to sex hormonal therapy including, but not limited to, the
- •Deep vein thrombophlebitis or thromboembolic disorders.
- •Cerebral vascular or coronary artery disease, chronic untreated hypertension,
- •or migraines.
- •Benign or malignant liver tumor that developed during the use of oral
- •contraceptives or other estrogen-containing products.
- •Known or suspected estrogen-dependent neoplasia.
- •6. Subject has presence of disorders commonly accepted as contraindications to
- •combined oral contraceptives including, but not limited to, the following:
- •Undiagnosed abnormal vaginal bleeding.
- •Any neurovascular lesion of the eye or serious visual disturbance.
- •Any impairment of liver function or liver disease, or renal disease.
- •7. Subject has evidence of cervical dysplasia as documented by a CytoRich test
- •or Papanicolaou (PAP) smear test within 10 months before screening. If a PAP
- •smear has been done within 10 months prior to screening and results are
- •available (documentation is available at the study site) a cervical smear does
- •not need to be performed.
- •8. Subject has used oral hormonal contraception, ie, contraceptive pills,
- •within 3 months before admission to the study site on Day -1 of Treatment
- •9. Subject currently has a contraceptive implant such as Implanon* or Norplant®
- •in place, or has had removal of contraceptive implant within the 3 months
- •before admission to the study site on Day -1 of Treatment Period 1.
- •10. Subject currently has a contraceptive vaginal ring such as NuvaRing® in
- •place, or has had removal of contraceptive vaginal ring within the 3 months
- •before admission to the study site on Day 1 of Treatment Period 1.
- •11. Subject received hormone injections such as Depo Provera® or deposubQ
- •Provera 104, within the 3 months before admission to the study site on Day 1 of
- •Treatment Period 1.
- •12. Subject used a steroid hormone-containing IUD such as Mirena® within the
- •screening period from Day 28 until admission to the study site on Day 1 of
- •Treatment Period 1.
- •13. Subject used any prescription or nonprescription medication (including
- •herbal supplements), that are known
研究者
相似试验
已完成
不适用
Randomized, Blinded, 2 stage, 2-way Crossover Bioequivalence Study of Mentholatum 10% w/w Ibuprofen Gel and Ibuleve 10% w/w Ibuprofen Gel Administered as a Single Application of 125 mg in Healthy SubjectsNL-OMON51126The Mentholatum Company Ltd.54
已完成
不适用
Study of the rate of absorption of donepezil 10mg in the form of an orodispersible film versus donepezil 10mg in the form of an orodispersible tablet in healthy subjects under fasting conditionsMental and Behavioural DisordersAlzheimer's diseaseISRCTN89596264Applied Pharma Research [APR] (Switzerland)40
已完成
不适用
A randomized, double blind, two-way crossover clinical trial to evaluate of pharmacokinetic profiles of lacosamide in Korean subjectsKCT0003959Dong-A University Hospital48
进行中（未招募）
不适用
A randomized, double-blind, two way cross-over, proof of concept study to compare the efficacy, safety, pharmacokinetics and pharmacodynamics of two-week oral administration of QAV680 versus placebo, with an extended open-label inhaled corticosteroid period, in steroid-free, mild to moderate persistent asthma patientsEUCTR2008-005168-15-DEovartis Pharma Services AG50
已完成
2 期
Safety , Pharmacokinetics and efficacy of QAV680 in asthma patientsCTRI/2009/091/000282ovartis Healthcare Pvt Ltd50