A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine
Study Overview
Brief Summary
A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers
Detailed Description
A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •19~55 years healthy male
- •Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
- •Subjects who agree to keep contraceptive methods during the clinical trial.
Exclusion Criteria
- •Subjects who are allergic to investigational drug.
- •Subjects who have a medical history which can affect the clinical trial.
- •Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
- •Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
Arms & Interventions
Group 1 of part 1
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2
Intervention: Rosuvastatin (Drug)
Group 1 of part 1
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2
Intervention: Rosuvastatin and Telmisartan/Amlodipine (Drug)
Group 2 of part 1
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2
Intervention: Telmisartan/Amlodipine (Drug)
Group 2 of part 1
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2
Intervention: Rosuvastatin and Telmisartan/Amlodipine (Drug)
Group 1 of part 2
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2
Intervention: Rosuvastatin (Drug)
Group 1 of part 2
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2
Intervention: Rosuvastatin and Telmisartan/Amlodipine (Drug)
Group 2 of part 2
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2
Intervention: Telmisartan/Amlodipine (Drug)
Group 2 of part 2
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2
Intervention: Rosuvastatin and Telmisartan/Amlodipine (Drug)
Outcomes
Primary Outcomes
AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine
Time Frame: 72hours, 144hours
Secondary Outcomes
- AUClast,ss of Rosuvastatin(72hours)
- AUCinf,ss of Rosuvastatin(72hours)
- Tmax,ss of Rosuvastatin(72hours)
- t1/2 of Rosuvastatin(72hours)
- AUClast,ss of Telmisartan, Amlodipine(144hours)
- AUCinf,ss of Telmisartan, Amlodipine(144hours)
- Tmax,ss of Telmisartan, Amlodipine(144hours)
- t1/2 of Telmisartan, Amlodipine(144hours)