A Randomized,Open-label,Six-sequence,Three-period,Three-treatment,Multiple Dosing Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid After Oral Administration in Healthy Male Volunteers

Unimed Pharmaceuticals0 个研究点目标入组 42 人开始时间: 2013年2月最近更新: 2013年8月22日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Unimed Pharmaceuticals
入组人数: 42
主要终点: AUCτ,ss / Cmax of pregabalin and thioctic acid

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

A randomized, open-label, six-sequence, three-period, three-treatment, multiple dosing clinical trial to investigate the pharmacokinetic drug interaction between Pregabalin and Thioctic acid after oral administration in healthy male volunteers.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
盲法: None

入排标准

年龄范围: 20 Years 至 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Body weight ae least 50kg and BMI(body mass index) within the range of 18 to 27kg/m2
•Provision of signed written informed consent
•Acceptable physical examination and clinical examination, during screening

排除标准

•A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
•A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
•A subject with history of allergies including study drug (pregabalin or thioctic acid) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
•A subject whose lab test results are as follows: AST(SGOT), ALT(SGPT) > 1.5 x upper limit of reference range
•Presence or history of drug abuse or positive result in urine drug screening test
•Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
•Participation in clinical trials of any drug within 60 days prior to the participation of the study
•Blood donation during 2 months or apheresis during 1 month before the study
•Use of alcohol over 21 units/weeks
•Smoker who smoke more than 10 cigarettes per day or who cannot stop smoking during the study period (from 24 hours before hospitalization to discharge)
•Use of caffeine drink during the study period(from 24 hours before hospitalization to discharge)
•A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products during the study
•Judged to be inappropriate for the study by the investigator after reviewing clinical laboratory results or other reasons.