KCT0002657已完成未知
A randomized, open-label, six-sequence, three-period, three-treatment, multiple dosing clinical trial to investigate the pharmacokinetic drug interaction between Pregabalin and Tramadol ER after oral administration in healthy male volunteers
Sam Chun Dang Pharm.0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 45(Year)（—）
- 性别
- All
入选标准
- •(1) Healthy adult Korean males between the ages of 19 and 45 years
- •(2) Subjects with body weights from 55 to 90 kg and with body mass index (BMI) from 18.0 to 27.0
- •? BMI (kg/m2) = weight(kg)/{height(m)}2
- •(3) Subjects who are informed of the investigational nature of this study and who voluntarily agree to participate and sign an IRB-approved informed consent form prior to receiving any of the screening procedures
排除标准
- •(1) Subjects with evidence or a history of clinically significant hepatic, renal, neurologic, immunological, pulmonary, musculoskeletal, endocrine, hematological, neoplastic, cardiovascular, psychiatric diseases
- •(2) Subjects with evidence or a history of gastrointestinal disease (e.g, peptic ulcer, gastritis, gastric cramp, gastroesophageal reflex disease, Chron’s disease) or with history of gastrointestinal surgery (except simple appendectomy or herniorrhaphy) that may affect assessment of safety, PK and PD characteristics of study drug.
- •(3) Subjects with a history of hypersensitivities to the drug, including investigational drugs or other drugs (e.g., aspirin and antibiotics) or with a history of clinically significant hypersensitivities.
- •(4) Subjects with evidence of genetic problems for administration of lactose content of sanctions including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabosorption
- •(5) Subjects with the following results at screening
- •? Creatinine clearance from Modification of Diet in Renal Disease (MDRD) equation: <80 mL/min
- •(Modification of Diet in Renal Disease (MDRD) equation: Glomerular filtration rate (mL/min/1.73 m2) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American))
- •?HbsAg, HCV antibody, HIV antibody positive
- •?Serum AST (SGOT) or ALT (SGPT) level >1. 5 times the upper limit of the normal range or total bilirubin > 2.0 mg/dL
- •?QTc interval > 450 ms confirmed more than three times after subjects relieved
- •?Any of the following vital sign abnormalities measured in situ after resting for more than three minutes
- •?Systolic blood pressure: <90 mmHg or >140 mmHg
- •?Diastolic blood pressure: <60 mmHg or > 90 mmHg
- •(7) Subjects with a history of drug abuse or a positive urine screening for drug abuse
- •(8) Subjects who have taken any prescribed or herbal medicine within two weeks prior to study drug administration or any non-prescribed medicine or vitamin supplement within one week prior to study drug administration (if all other conditions are satisfied, these subjects may be eligible for the trial as judged by the investigator)
- •(9) Subjects who have participated in any other clinical trial within three months prior to study drug administration
- •(10) Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
- •(11) Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the admission period.
- •(12) Smokers (except for those who had quit for at least three months before the first administration of the IP).
- •(13) Subjects who consume more than 1000 mg per day (approximately 10 cups) for at least three months or are unable to abstain from products containing caffeine (e.g. coffee, green tea, black tea and sodas) during the entire admission period.
- •(14) Subjects who consume or are unable to abstain from products containing grapefruit from 72 hours hours before admit to trial center to the entire admission period.
- •(15) Subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.
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