The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

Study Overview

• Status: Completed
• Conditions: Hypertension; Hyperlipidemia
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Rosuvastatin and Telmisartan/Amlodipine; Drug: Telmisartan/Amlodipine

Detailed Description

A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, Korea, Republic of, 120-752
      • Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Rosuvastatin; Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days; Other Names: Crestor; Drug: Rosuvastatin and Telmisartan/Amlodipine; Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days; Other Names: Crestor and Twynsta
Experimental: 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	Drug: Rosuvastatin and Telmisartan/Amlodipine; Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days; Other Names: Crestor and Twynsta; Drug: Telmisartan/Amlodipine; Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days; Other Names: Twynsta
Experimental: 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	Drug: Rosuvastatin; Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days; Other Names: Crestor; Drug: Rosuvastatin and Telmisartan/Amlodipine; Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days; Other Names: Crestor and Twynsta
Experimental: 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	Drug: Rosuvastatin and Telmisartan/Amlodipine; Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days; Other Names: Crestor and Twynsta; Drug: Telmisartan/Amlodipine; Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days; Other Names: Twynsta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine	72hours, 144hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Kyungsoo Park, MD, Ph.D., Yonsei University

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 13, 2015

Study Record Updates

• Last Update Posted (Estimate): June 24, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Rosuvastatin Calcium; Telmisartan; Telmisartan amlodipine combination
• Other Study ID Numbers: JLP-1401-P1-DI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No