TCTR20180312002已完成未知
CYP3A and drug transporters activity changes in Thai elderly with or without chronic kidney disease using a microdose cocktail
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 60
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
- 20 Years 至 90 Years（—）
- 性别
- All
入选标准
- •Inclusion criteria
- •Group 1 healthy young subjects
- •1Subjects who are Thai male or female, aged 20 to 40 years (inclusive).
- •2Subjects whose BMI is 18-25 kg/m2 (inclusive).
- •3Subjects who are healthy by medical history, physical examination and vital signs.
- •4Subject whose screening visit laboratory values of blood tests including complete blood count, fasting blood sugar, blood urea nitrogen, serum creatinine, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, albumin, alpha-1-acid glycoprotein, total cholesterol, triglyceride, LDL cholesterol, HDL cholesterol, electrolytes, parathyroid hormone, Hepatitis Bs-antigen, anti-HIV are within the normal range or showing no clinically significant abnormalities as confirmed by the clinical investigator.
- •5eGFR ≥90 ml/min/1.73 m2 as calculated by eGFR for Thai(73)
- •6For female subjects:
- •Female subject who is in childbearing potential must have serum β-HCG negative and agrees to use an acceptable birth control method from visit 1 to the last visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device (IUD) and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the last visit. Hormonal contraceptives are not acceptable.
- •Female subject who is in child bearing potential must agree not to become pregnant for the entire participation phase and must have a negative result for urine pregnancy test performing prior to dosing at phase I and phase II.
- •Female subjects can be those with non-childbearing potential which defined as female subjects with hysterectomy, both ovaries removed, surgically sterilized.
- •7Subjects are able to understand the requirements of the study and voluntarily sign and date an informed consent, approved by the Independent Ethic Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- •Group 2: the relatively healthy elderly
- •1Subjects who are Thai male or female, aged ≥60 years.
- •2Subjects whose BMI is 18-30 kg/m2 (inclusive).
- •3Subjects who are healthy by medical history, physical examination and vital signs.
- •4Subject whose screening visit laboratory values of blood tests including complete blood count, fasting blood sugar, blood urea nitrogen, serum creatinine, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, albumin, alpha-1-acid glycoprotein, total cholesterol, triglyceride, LDL cholesterol, HDL cholesterol, electrolytes, parathyroid hormone, Hepatitis Bs-antigen, anti-HIV are within the normal range or showing no clinically significant abnormalities as confirmed by the clinical investigator.
- •5eGFR >80 ml/min/1.73 m2 as calculated by eGFR for Thai
- •6Subjects are able to understand the requirements of the study and voluntarily sign and date an informed consent, approved by the Independent Ethic Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- •Group 3: the elderly with CKD
- •1Subjects who are Thai male or female, aged ≥60 years.
- •2Subjects whose BMI is 18-30 kg/m2 (incl
排除标准
- •Exclusion criteria
- •Group 1 healthy young subjects
- •1Subjects who are with a history/evidence of allergy or hypersensitivity to dabigatran etexilate, midazolam, pitavastatin, rosuvastatin, atorvastatin and rifampicin.
- •2Subjects who have a history of any illness that, in the opinion of the clinical investigator, might confound the result of study or pose an additional risk in administrating study drug to the subjects. This may include but not limited to: a history of relevant drug or food allergies; history or cardiovascular disease, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or present of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
- •3Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking a least one day before the study and until the completion of the study phase.
- •4Subjects who are with a history of alcoholic (more than 2 years) or moderate drinker (more than 3 drinks per day †one is equal to one unit of alcohol: - one glass of mine, half pine of beer or one measure of spirit) or subject who are with a history of any drug abuse.
- •5Subjects who receive of any medical prescription within 14 days before the first administration of the microdose cocktail, especially drug related to the study drug metabolizing enzyme
- •6Female subjects who are pregnant or breast feeding.
- •7Subjects who are participating in any investigational drug study or had been in any investigational drug study within 3 months prior to the screening visit.
- •Group 2: the relatively healthy elderly
- •1Subjects who are with a history/evidence of allergy or hypersensitivity to dabigatran etexilate, midazolam, pitavastatin, rosuvastatin, atorvastatin and rifampicin.
- •2Subjects with hypertension and diabetes mellitus or and other major systemic disease.
- •3Subjects with history of renal transplantation or liver transplantation
- •4Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking a least one day before the study and until the completion of the study phase.
- •5Subjects who are with a history of alcoholic (more than 2 years) or moderate drinker (more than 3 drinks per day †one is equal to one unit of alcohol: - one glass of mine, half pine of beer or one measure of spirit) or subject who are with a history of any drug abuse.
- •6Subjects who are participating in any investigational drug study or had been in any investigational drug study within 3 months prior to the screening visit.
- •Group 3: the elderly with CKD
- •1Subjects who are with a history/evidence of allergy or hypersensitivity to dabigatran etexilate, midazolam, pitavastatin, rosuvastatin, atorvastatin.
- •2Subjects with history of renal transplantation, liver transplantation, hemodialysis and peritoneal dialysis.
- •3Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking a least one day before the study and until the completion of the study phase.
- •4Subjects who are with a history of alcoholic (more than 2 years) or moderate drinker (more than 3 drinks per day †one is equal
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