ChiCTR-ONC-13003006Not yet recruitingPhase 1

Pharmacokinetic interaction between rosuvastatin and telmisartan

Chinese University of Hong Kong0 sites24 target enrollmentStarted: September 21, 2014Last updated: January 4, 2016

Trial Snapshot

Phase: Phase 1
Status: Not yet recruiting
Sponsor: Chinese University of Hong Kong
Enrollment: 24
Primary Endpoint: Differences in statin pharmacokinetic parameters with and without telmisartan

To test the pharmacokinetic interaction between rosuvastatin and telmisartan.

•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).

:Rosuvastatin 10mg for two days and Telmisartan 40mg for 14 days

Differences in statin pharmacokinetic parameters with and without telmisartan

Sponsor