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

NCT ID: NCT01992601

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-01-31

Brief Summary

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.

Conditions

Healthy Volunteer

Keywords

Drug interaction; Rosuvastatin; Telmisartan; Pharmacokinetic; (Pharmacokinetics and Drug Interaction)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital, Yonsei University

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 24998012 (View on PubMed)

Other Identifiers

YH16410-101

Identifier Type: -

Identifier Source: org_study_id