The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

Phase 1

Completed

• Conditions: Hyperlipidemia; Hypertension
• Interventions: Drug: Rosuvastatin; Drug: Telmisartan/Amlodipine; Drug: Rosuvastatin and Telmisartan/Amlodipine

• Registration Number: NCT02387619
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

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 Timeline

• Study Start: 2015-02
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-13
• Study Completion: 2015-07
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1 of part 1	Rosuvastatin	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
Group 1 of part 1	Rosuvastatin and Telmisartan/Amlodipine	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
Group 2 of part 1	Telmisartan/Amlodipine	Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2
Group 2 of part 1	Rosuvastatin and Telmisartan/Amlodipine	Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2
Group 1 of part 2	Rosuvastatin	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
Group 1 of part 2	Rosuvastatin and Telmisartan/Amlodipine	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
Group 2 of part 2	Telmisartan/Amlodipine	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
Group 2 of part 2	Rosuvastatin and Telmisartan/Amlodipine	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

Primary Outcome Measures

Name	Time	Method
AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine	72hours, 144hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yonsei University Health System; 🇰🇷 Seoul, Seodaemun-gu, Korea, Republic of