CUHK_CCT00352
2013-01-19
Prospective
Nil
CUHK
CUHK
N/A
Benny Fok
Flat B, 6/F, Block B, Staff Quarters, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
(852) 2632-3377
bfok@cuhk.edu.hk
The Chinese University of Hong Kong
Brian Tomlinson
Department of Medicine and Therapeutics, 9/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
(852) 2632-3139
btomlinson@cuhk.edu.hk
The Chinese University of Hong Kong
Pharmacokinetic interaction between rosuvastatin and telmisartan
Pharmacokinetic interaction between rosuvastatin and telmisartan
他汀類藥物與替米沙坦藥物代謝動力學相互作用的研究
Rosuvastatin-telmisartan interactions
Hong Kong
Yes
2012-10-15
Hyperlipidaemia, hypertension
Drug
Rosuvastatin 10mg/ Telmisartan 40mg
Rosuvastatin (2 days)/ Telmisartan (14 days)
Nil
Body mass index : 18-30 kg/m2; treatment with rosuvastatin 10 mg daily with or without other lipid-modifying drugs for at least for 4 weeks according to the current HA guidelines; borderline high or high blood pressure (systolic blood pressure ≥120 mmHg or diastolic blood pressure ≥ 80 mmHg) with or without anti-hypertensive treatment other than angiotensin-converting enzyme inhibitors (ACEIs) or ARBs.
History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study; clinically significant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test or upon Investigator decision; adjustment of lipid-lowering treatment within 6 weeks prior to the study in patients with hyperlipidaemia; treatment of telmisartan or other ARBs or ACEIs within 4 weeks prior to the study; adjustment of concomitant medications within 4 weeks prior to the study; taking other drugs known to interact with rosuvastatin or telmisartan; volunteer in any clinical drug study within 2 months prior to this study; history of allergy or hypersensitivity to rosuvastatin or telmisartan; type 2 diabetes with poor glyceamic control (HbA1c> 8.5%); impaired hepatic or renal disease function (alanine aminotransferase [ALT] >1.5 times upper limit of normal range; serum creatinine > 140 mol/L); regular heavy alcohol consumption (>21 units of alcohol per week).
18
70
Both Male and Female
Interventional
Non-randomized
Historical control
Open label
Single group
2013-03-18
24
Unknown
Differences in statin pharmacokinetic parameters with and without telmisartan
Difference in pharmacokinetic parameters and interactions among genotype groups
2014-02-20
ChiCTR-ONC-13003006
2013-01-19
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