TCTR20220906003Unknown1 期
Open-label, randomized, single dose, two-period, two-treatment cross-over bioequivalence study of Dienogest 2 mg tablets from Naari Pharma Pvt. Ltd. - India vs Visanne 2 mg tablets, from Bayer Weimar GmbH UND Co.KG, Weimar, Germany in healthy female subjects under fasting conditions
Abbott Laboratories Limited, Thailand0 个研究点目标入组 44 人开始时间: 2022年9月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 44
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 Years 至 55 Years（—）
- 性别
- Female
入选标准
- •Normal females, of of 18-55 years of age with body mass index in the range of 18.50 - 30.00 kg/m2
- •Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study
- •Willing to take appropriate measures to prevent pregnancy during the study, such as total abstinence from sexual activities or the use of condom for at least 14 days prior to dosing period I and willing to continue until 1 week from end of the study.
- •Willing to be available for the entire study period and to comply with protocol requirements
- •Normal health status is to be determined by baseline medical and medication history, at the time of screening and vital signs (sitting blood pressure, pulse rate, respiratory rate and forehead-surface temperature) measurements and clinical examination at the time of screening as well as at check-in during each study period
- •With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis
- •With a normal or clinically non-significant 12-lead Electrocardiogram (ECG)
- •Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study)
- •Able to communicate effectively with study personnel
- •Non-alcoholic [i.e. alcohol consumption not exceeding 7 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor)] and cannot stop at least 24 hours before the study drug administration and until the completion of each period of the study.
- •For subjects who still have a uterus
- •oNegative urine pregnancy test during screening and each period before dosing
排除标准
- •Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, laboratory evaluations, ECG, obstetrics and gynecological history along with breast examination that showed sign of significant disease]
- •Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood-forming organs
- •History of allergy or hypersensitivity intolerance to Dienogest or its formulation excipients
- •Significant history or presence of sign and symptoms of arterial and cardiovascular disease (e.g., myocardial infarction, Cerebrovascular accident, ischemic heart disease), ophthalmic vascular disease, diabetes mellitus with vascular involvement, severe hepatic disease as long as liver function values have not returned to normal, active venous thromboembolic disorder, liver tumors (benign or malignant), known or suspected sex hormone-dependent malignancies, undiagnosed abnormal vaginal bleeding, migraine with focal aura, depression, bronchial asthma
- •Any present disease or condition like diabetes, psychosis or others which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system
- •History or presence of significant easy bruising or bleeding
- •Any major illness or hospitalized within 90 days prior to the first dosing
- •Any other clinical condition like diarrhea or vomiting within 3 days prior to first dosing
- •History or presence of significant gastric and/or duodenal ulceration within past 1 year prior to first dosing
- •History of any gastrointestinal disease which could affect drug absorption
- •Use of any hormone replacement therapy within 3 months prior to the first dose of study medication
- •Use of any depot injection or an implant of any drug within 6 months prior to first dosing and throughout the study periods
- •Use of any prescribed medication 14 days or within 5 half-lives (whichever longer) of the drug, whichever is longer prior to first dose of study medication
- •Use of any OTC products (including herbal drugs and vitamin supplements) within 7 days or within 5 half-lives of the drug, whichever is longer prior to the first dose of study medication
- •Subjects who have received a known Investigational drug within ten elimination half-life of the administered drug prior to the first dose of study medication
- •Subjects who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater
- •A positive hepatitis screen (includes subtypes B & C) and HIV antibody
- •Use of any recreational drug or history of drug addiction
- •History or evidence of drug dependence or of alcoholism or of moderate alcohol use
- •Consumption of alcohol or alcoholic products within 24.00 hrs prior to dosing of each period of the study
- •Positive alcohol breath or urine drug of abuse tests during check-in in each study period
- •History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture
- •Difficulty in swallowing solids like tablets or capsules
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the subject's participation in this study
- •Consumption of xan
研究者
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