JPRN-jRCT2080221540未知1 期
Pharmacokinetic study of olmesartan medoxomil/amlodipine 20/5 mg tablet in Chinese healthy adult volunteers
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 10
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
- >= 18age old 至 <= 45age old（—）
- 性别
- All
入选标准
- •1.Healthy male or female;
- •2.Aged 18 to 45 years;
- •3.Body weight >= 50 kg, body mass index (BMI) [weight (kg) / height 2 (m2)] is between 19 and 24;
- •4.Healthy status was confirmed by medical history, comprehensive physical examination and laboratory tests;
- •5.Subjects signed informed consent form.
排除标准
- •1.Unable or unwilling to sign the informed consent form;
- •2.Clinically significant abnormalities was found after physical examination, or laboratory tests showed clinically significant abnormal values;
- •3.Any of the result of serological screening tests, including: HIV antibody, HBV (HBeAg, HBsAg), HCV antibody, TPPA, is positive;
- •4.Present with a history of cardiovascular, liver, kidney, gastrointestinal, or neurological/mental diseases;
- •5.With known hypersensitivity to the investigational drug or any ingredient of the investigational drug;
- •6.Having blood donation within the last 3 months;
- •7.Systolic blood pressure below 100 mmHg, and/or diastolic blood pressure below 50 mmHg at screening;
- •8.Pregnant or breast-feeding women, or women of childbearing potential who failed to take effective contraceptive measures;
- •9.With a history of alcohol dependence or drug abuse, and/or positive result in drug screening or alcohol breath test;
- •10.The subjects who required elective surgery during the study;
- •11.Subjects who had participated in drug clinical trial one month before study entry, or had plan to participate in other drug clinical trial during this study;
- •12.The subjects who received any medication two weeks before study entry (excluding daily dose of not more than 1 g paracetamol);
- •13.The subjects who smoke > 15 cigarettes/day during the 12 months before screening, and/or positive for tobacco screening test;
- •14.The ineligibility of subjects to participate in this study was evaluated by the investigator.
研究者
相似试验
进行中（未招募）
1 期
The efficacy and safety of olmesartan medoxomil/amlodipine fixed combination in patients with mild to moderately elevated blood pressure. An international randomized, double-blind, 10-week clinical InvestigatioEUCTR2014-003470-17-ROKrka, d.d. Novo mesto997
进行中（未招募）
1 期
The efficacy and safety of olmesartan medoxomil/amlodipine fixed combination in patients with mild to moderately elevated blood pressure. An international randomized, double-blind, 10-week clinical InvestigatioPrimary arterial hypertensionMedDRA version: 17.1Level: LLTClassification code 10020775Term: Hypertension arterialSystem Organ Class: 100000004866EUCTR2014-003470-17-DEKrka, d.d. Novo mesto800
进行中（未招募）
1 期
The efficacy and safety of olmesartan medoxomil/amlodipine fixed combination in patients with grade 1 to grade 2 arterial hypertension. An international randomized, double-blind, 10-week multi-factorial clinical study.Primary arterial hypertensionMedDRA version: 18.0Level: LLTClassification code 10020775Term: Hypertension arterialSystem Organ Class: 100000004866EUCTR2014-003470-17-HUKrka, d.d. Novo mesto997
已完成
不适用
comparison of Therapy with Olmesartan medoxomil monotherapy or azelnidipine and olmesartan medoxomil combination in hypertensive patients with chronic KIdney diseaseHypertensive patients with CKD under the treatment of the angiotensin receptor blocker(ARB), olmesartan medoxomil 20mg/dayJPRN-UMIN000004489iigata University80
进行中（未招募）
不适用
Treat-to-target study of olmesartan medoxomil and an add-on treatment algorithm consisting of hydrochlorothiazide and amlodipine besylate in patients with mild to moderate hypertension - Treat to target-OLMETREATMild to moderate hypertensionEUCTR2005-004659-36-PTDaiichi Sankyo Europe GmbH720