A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer (YH16410 DDI)

This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also investigate drug interaction between separate and combination administration.

Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day administration, 16 days washout after 6th day of administration.

The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over design during 2 each period.

The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a cross-over design during 2 each period.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male and female aged 20 to 50 with a body mass index(BMI) between 19 and 27 kg/m2
2. Acceptable medical history, physical examination, laboratory tests and EKG, during screening
3. Provision of signed written informed consent •20~50 yrs old, healthy Korean Subjects

Exclusion Criteria:

1.History of and clinically significant disease 2.Sitting blood pressure meeting the following criteria at screening: 150 ≤ systolic blood pressure ≤90 (mmHg) and 95 ≤ diastolic blood pressure ≤ 50 (mmHg) amd 100 ≤ Heart rate ≤ 40 3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.

4. Administration of other investigational products within 90 days prior to the first dosing.

5. Administration of herbal medicine within 30 days or administration of ethical drugs within 14 days or administration of over-the-counter (OTC) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).

6.Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of screening 7. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; This arm is consist of 12 subject. Crestor 20mg alone for 6 day during period 1. Crestor 20mg and Micardis 80mg for 6 day during period 2.	Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg); For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period. For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period.
Experimental: 2; This arm is consist of 12 subject. Crestor 20mg and Micardis 80mg for 6 day during period 1. Crestor 20mg alone for 6 day during period 2.	Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg); For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period. For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period.
Experimental: 3; This arm is consist of 12 subject. Micardis 80mg alone for 6 day during period 1. Crestor 20mg and Micardis 80mg for 6 day during period 2.	Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg); For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period. For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period.
Experimental: 4; This arm is consist of 12 subject. Crestor 20mg and Micardis 80mg for 6 day during period 1. Micardis 80mg alone for 6 day during period 2.	Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg); For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period. For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC	AUC τ,ss of Rosuvastatin and Telmisartan	72hr
Cmax	Cmax,ss of Rosuvastatin and Telmisartan	72hr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC	AUC last,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan	72hr
AUC	AUC inf,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan	72hr
Tmax	Tmax,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan	72hr
t1/2	t1/2 of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan	72hr
Cmin	Cmin,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan	72hr
AUC	AUCτ,ss of N-desmetyl Rosuvastatin	72hr
Cmax	Cmax,ss of N-desmetyl Rosuvastatin	72hr

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Publications and helpful links

General Publications

• Son M, Kim Y, Lee D, Roh H, Son H, Guk J, Jang SB, Nam SY, Park K. Pharmacokinetic interaction between rosuvastatin and telmisartan in healthy Korean male volunteers: a randomized, open-label, two-period, crossover, multiple-dose study. Clin Ther. 2014 Aug 1;36(8):1147-58. doi: 10.1016/j.clinthera.2014.06.007. Epub 2014 Jul 3.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 22, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Telmisartan; Pharmacokinetic; Rosuvastatin; Drug interaction; (Pharmacokinetics and Drug Interaction)
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Rosuvastatin Calcium; Telmisartan
• Other Study ID Numbers: YH16410-101