JPRN-jRCT2071200065已完成1 期
Phase I/II study to investigate the pharmacokinetics, safety, and hormonal concentrations after single and multiple doses of LF111 (drospirenone) in healthy Japanese women
Kikuyama Ryoko0 个研究点目标入组 12 人开始时间: 2020年12月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
- >= 20age old 至 <= 35age old（—）
- 性别
- Female
入选标准
- •Healthy premenopausal Japanese women aged 20 years or older and 35 years or younger at the time of informed consent.
- •-Non-smokers (those who have not smoked within 6 months before obtaining informed consent).
- •-Individuals who have a normal menstrual cycle (25 days to 38 days) including the menstrual period (bleeding from 3 days to 7 days) more than once before obtaining informed consent.
- •-Individuals who agree on appropriate contraceptive methods other than oral contraceptives and intrauterine luteal hormone release system, including partners throughout the study.
排除标准
- •-Individuals who have a positive pregnancy test at the time of screening.
- •-Individuals who are pregnant (childbirth, miscarriage or abortion) or breastfed within 3 months before obtaining informed consent.
- •-A cervical smear (cytology) at screening that was determined to be positive (other than negative (NILM) by Bethesda System 2014).
- •-Individuals who currently have or have a history of thrombophlebitis, venous or arterial thromboembolic disease (thrombosis, pulmonary embolism, cerebral infarction, myocardial infarction).
- •-Individuals with severe nervous system disease, digestive system disease, liver disease, or a problem taking the study drug.
- •-Individuals assessed by the investigator as having clinically significant abnormalities in labolatory test at screening.
- •-Individuals with renal or adrenal insufficiency or hepatic impairment.
- •-Individuals with a history of intolerance to oral contraceptives.
- •-Individuals who are or suspected of alcoholism, drug addiction.
- •-Individuals who participated in another clinical trial within 16 weeks before administration of the investigational drug and received the investigational drug or who are currently participating in another clinical trial.
- •-Personnel of the study site or family members of the investigator or subinvestigator.
- •-Individuals who received 200 mL of blood within 4 weeks before administration of the investigational drug or 400 mL or more of blood within 16 weeks, or Individuals who donated blood components within 2 weeks before administration of the investigational drug.
- •-Individuals known to be allergic to any of drug.
- •-Individuals who regularly take the following drugs:
- •Hormonal preparations (GnRH agonists, GnRH antagonists, estrogens, progestins, estogens/progestins) (all use in the last 6 months excluded)
- •Agents known to induce hepatic drug-metabolizing enzymes (e.g. Rifampicin, dexamethasone, barbiturates, anticonvulsants, St. John's wort)
- •Drugs known to inhibit CYP3A4 (e.g. Ketoconazole, verapamil, cimetidine, and macrolides)
- •Drugs that raise serum potassium (e.g.Aldosterone antagonist,Potassium-sparing diuretics)
- •-Individuals who consume a lot of xanthine-containing beverages (e.g. Five or more cups of coffee per day)
- •-Individuals whose temperature at screening falls outside the range of 35-37.5 deg C.
- •-ECGs at screening that are clinically abnormal.
- •-Individuals with undiagnosed uterine bleeding.
- •-Individuals with malignancy or a history of malignancy within 5 years before obtaining informed consent.
- •-Individuals with a history of the following.
- •-Individuals undergoing hysterectomy
- •Gastrointestinal, hepatic, or renal disease that may affect the Pharmacokinetics of the drug
- •Thromboembolism
- •Cerebrovascular disorder
- •Migraine with aura
- •Adrenal insufficiency
- •Pancreatitis
- •Jaundice of pregnancy
- •Surgery with general anesthesia within 3 months
- •Pulmonary tuberculosis
- •-Individuals who the investigator judges be inappropriate.
研究者
相似试验
招募中
1 期
AKP-009 Phase I clinical trialBenign prostatic hyperplasiaJPRN-jRCT2071230052Shimomiya Kazuhiro81
已完成
Unknown
Studying the safety and the pharmacokinetics after single dosing of KDF2001 in healthy adultEndocrine, nutritional and metabolic diseasesKCT0009163Kyung Dong Pharmaceutical40
已完成
不适用
A phase I study to investigate the pharmacokinetics, safety and tolerability of four different dosing regimens of GRC 17536 in healthy male volunteers using tablet formulation.Pijn en luchtwegaandoeningenPain and respiratory conditionsNL-OMON42613Glenmark Pharmaceuticals SA28
已完成
1 期
A single-center study of the safety, tolerability and pharmacokinetics of a single concentration of topical SM04554 (0.25% concentration) solution in male subjects with androgenetic alopecia.Androgenetic alopecia (AGA)Skin - Dermatological conditionsMetabolic and Endocrine - Other endocrine disordersHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersACTRN12615000980538Samumed Pacific Pty Ltd25
进行中（未招募）
1 期
Study of how tafluprost is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.Glaucoma or Ocular HypertensionMedDRA version: 18.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2013-004302-26-GBSanten Oy18