A Randomized, Double-blind, 2-Way Crossover Bioequivalence and Adhesion Study of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components and Currently Marketed EVRA® in Healthy Adult Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) for NGMN
研究概览
简要总结
The purpose of this study is to determine the bioequivalence of the hormones (ie, norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal contraceptive patch and to evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component, as compared to the currently marketed EVRA patch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant has a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2), inclusive, and body weight not to exceed 100 kilogram
- •Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This will be documented and signed by the investigator in the source document
- •Participant must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening and negative urine pregnancy tests on Day -1 of each treatment period
- •Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •Participant must be surgically sterile with intact ovaries, abstinent, or, if sexually active, be practicing an effective method of non-hormonal birth control (example [eg], intrauterine device [IUD], double barrier method, male partner sterilization) before admission and throughout the study
排除标准
- •Participant 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 participant or that could interfere with the interpretation of the study results
- •Participant has clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening as deemed appropriate by the investigator
- •Participant has abnormal thyroid stimulating hormone level at screening
- •Participant has clinically significant abnormal 12-lead ECG, vital signs, or physical examination at screening as deemed appropriate by the investigator
- •Participant has a history or presence of disorders commonly accepted as contraindications to sex hormonal therapy including, but not limited to, the following: a) Deep vein thrombophlebitis or thromboembolic disorders; b) Cerebral vascular or coronary artery disease, chronic untreated hypertension, or migraines; c) Benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products; d) Known or suspected estrogen-dependent neoplasia
研究组 & 干预措施
Group 1: Sequence AB (Right/Left)
A single patch of currently marketed EVRA patch (Treatment A) will be applied to the right buttock of participants on Day 1 of treatment period 1, followed by application of a single patch of transdermal contraceptive using the newly sourced adhesive component HMW PIB (Treatment B) to left buttock of participants on Day 1 of treatment period 2. The treatment periods will be separated by a washout period of 21 days.
干预措施: HMW PIB patch (NGMN+EE) (Treatment B) (Test) (Drug)
Group 2: Sequence BA (Right/Left)
Treatment B will be applied to the right buttock of participants on Day 1 in Period 1 followed by Treatment A to the left buttock on Day 1 in Period 2. The treatment periods will be separated by a washout period of 21 days.
干预措施: HMW PIB patch (NGMN+EE) (Treatment B) (Test) (Drug)
Group 3: Sequence AB (Left/Right)
Treatment A will be applied to the left buttock of participants on Day 1 in Period 1 followed by Treatment B to the right buttock on Day 1 in Period 2. The treatment periods will be separated by a washout period of 21 days.
干预措施: HMW PIB patch (NGMN+EE) (Treatment B) (Test) (Drug)
Group 4: Sequence BA (Left/Right)
Treatment B will be applied to the left buttock of participants on Day 1 in Period 1 followed by Treatment A to the right buttock on Day 1 in Period 2. The treatment periods will be separated by a washout period of 21 days.
干预措施: HMW PIB patch (NGMN+EE) (Treatment B) (Test) (Drug)
Group 2: Sequence BA (Right/Left)
Treatment B will be applied to the right buttock of participants on Day 1 in Period 1 followed by Treatment A to the left buttock on Day 1 in Period 2. The treatment periods will be separated by a washout period of 21 days.
干预措施: EVRA patch (NGMN+EE) (Treatment A) (Reference) (Drug)
Group 4: Sequence BA (Left/Right)
Treatment B will be applied to the left buttock of participants on Day 1 in Period 1 followed by Treatment A to the right buttock on Day 1 in Period 2. The treatment periods will be separated by a washout period of 21 days.
干预措施: EVRA patch (NGMN+EE) (Treatment A) (Reference) (Drug)
Group 3: Sequence AB (Left/Right)
Treatment A will be applied to the left buttock of participants on Day 1 in Period 1 followed by Treatment B to the right buttock on Day 1 in Period 2. The treatment periods will be separated by a washout period of 21 days.
干预措施: EVRA patch (NGMN+EE) (Treatment A) (Reference) (Drug)
Group 1: Sequence AB (Right/Left)
A single patch of currently marketed EVRA patch (Treatment A) will be applied to the right buttock of participants on Day 1 of treatment period 1, followed by application of a single patch of transdermal contraceptive using the newly sourced adhesive component HMW PIB (Treatment B) to left buttock of participants on Day 1 of treatment period 2. The treatment periods will be separated by a washout period of 21 days.
干预措施: EVRA patch (NGMN+EE) (Treatment A) (Reference) (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) for NGMN
时间窗: Pre-dose to 168 hours post-dose
Area under the concentration versus time curve from zero (patch application) to 168 hours of NGMN in plasma will be assessed.
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) for EE
时间窗: Pre-dose to 240 hours post-dose
Area under the concentration versus time curve from zero (patch application) to 240 hours of EE in plasma will be assessed.
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for NGMN
时间窗: Pre-dose to 240 hours post-dose
Area under the concentration versus time curve from zero (patch application) to infinite time of NGMN in plasma will be assessed.
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for EE
时间窗: Pre-dose to 240 hours post-dose
Area under the concentration versus time curve from zero (patch application) to infinite time of EE in plasma will be assessed.
Cumulative Adhesion Percentage Ratio
时间窗: Baseline (Day 1) and every 24 hours after patch application up to patch removal at 168 hours (Day 8)
Adhesion of patches will be assessed in accordance with the European Medicines Agency (EMA) 0-5 scoring system. An estimated percentage of adhesion, to a whole integer, will be obtained (EMA 0-5 \[percentage (%)\] scoring). Estimated percentages of adhesion and corresponding EMA 0-5 score at each interval will be recorded in each participant's electronic case report form. The scoring system for adhesion of transdermal patches is indicated as follows: 0= greater than (\>) 90-100% of the patch area adheres; 1= \>80-90% of the patch area adheres; 2= \>70-80% of the patch area adheres; 3= \>60-70% of the patch area adheres; 4= \>50-60% of the patch area adheres; 5= 0-less than or equal to (\<=) 50% of the patch area adheres.
Mean Steady-State Concentration (Css) for Norelgestromin (NGMN)
时间窗: 48 to 168 hours post-dose
Mean steady-state concentration for NGMN after patch application, will be calculated as the mean concentration between 48 hours and 168 hours after patch application.
Mean Steady-State Concentration (Css) for Ethinyl Estradiol (EE)
时间窗: 48 to 168 hours post-dose
Mean steady-state concentration for EE after patch application, will be calculated as the mean concentration between 48 hours and 168 hours after patch application.
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) for EE
时间窗: Pre-dose to 168 hours post-dose
Area under the concentration versus time curve from zero (patch application) to 168 hours of EE in plasma will be assessed.
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) for NGMN
时间窗: Pre-dose to 240 hours post-dose
Area under the concentration versus time curve from zero (patch application) to 240 hours of NGMN in plasma will be assessed.
次要结局
- Irritation Potential(Screening, pre-dose, 168.5 and 192 hours post-dose)