NCT01356017已完成1 期
A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Telmisartan Between Free Combination of Telmisartan and S-amlodipine and Telmisartan Monotherapy in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Telmisartan AUC
研究概览
简要总结
The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of Telmisartan between free combination of Telmisartan and S-amlodipine and Telmisartan monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Between 20 aged and 50 aged in healthy males
- •Weight more than 55kg, BMI 19kg/m2-26kg/m2 at the period of screening
- •100mmHg ≤ sit SBP < 140mmHg and 60mmHg ≤ sit DBP < 90mmHg and 50 per/min ≤ Pulse rate < 95 per/min
- •AST, ALT, Total bilirubin < UNL x 1.5
- •Signed the informed consent from prior to the study participation
排除标准
- •Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
- •Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, hernia repair) affected by the absorption of medications
- •galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
- •Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of telmisartan or Amlodipine
- •drug abuse, or have a history of drug abuse showed a positive for the Triage TOX drug on urine : amphetamine, barbiturate, cocaine, opiates, benzodiazepines, THC(cannabinoids), methadone etc.
- •Subject takes herbal medicine within 30 days, ethical drug within 14 days, OTC within 7 days before the beginning of study treatment
- •unusual diet affected by the absorption, distribution, metabolism, excretion of medications
- •Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
- •Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
- •Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days
- •A heavy caffeine consumer (caffeine > 5 units/day),
- •A heavy alcohol consumer (alcohol > 21 units/week, 1 unit=pure alcohol 10mL) or cannot stop drinking
- •A heavy smoker (cigarette > 20 cigarettes per day)
- •Positive for Hepatitis B, Hepatitis C, HIV or syphilis
- •An impossible one who participates in clinical trial by investigator's decision including laboratory test result, EKG result
研究组 & 干预措施
Free combination of Telmisartan and S-amlodipine
Experimental
Subjects received Telmisartan 80mg and S-amlodipine 5mg once a day for 9 days. And subjects doesn't take any medications for 19 days.
干预措施: Telmisartan 80mg, S-amlodipine 5mg (Drug)
Telmisartan monotherapy
Active Comparator
Subjects received Telmisartan 80mg once a day for 9 days. And subjects doesn't take any medications for 19 days.
干预措施: Telmisartan 80mg (Drug)
结局指标
主要结局
Telmisartan AUC
时间窗: 0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr
次要结局
- Telmisartan Cmax(0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr)
- Telmisartan Tmax(0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr)
研究者
研究点 (1)
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