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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992601
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Tracking Information
First Submitted Date  ICMJE September 30, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date November 25, 2013
Study Start Date  ICMJE November 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
  • AUC [ Time Frame: 72hr ]
    AUC τ,ss of Rosuvastatin and Telmisartan
  • Cmax [ Time Frame: 72hr ]
    Cmax,ss of Rosuvastatin and Telmisartan
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
  • AUC [ Time Frame: 72hr ]
    AUC last,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
  • AUC [ Time Frame: 72hr ]
    AUC inf,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
  • Tmax [ Time Frame: 72hr ]
    Tmax,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
  • t1/2 [ Time Frame: 72hr ]
    t1/2 of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
  • Cmin [ Time Frame: 72hr ]
    Cmin,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
  • AUC [ Time Frame: 72hr ]
    AUCτ,ss of N-desmetyl Rosuvastatin
  • Cmax [ Time Frame: 72hr ]
    Cmax,ss of N-desmetyl Rosuvastatin
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer
Official Title  ICMJE A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)
  • 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.
    Intervention: Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)
  • 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.
    Intervention: Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)
  • 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.
    Intervention: Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2013)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01992601
Other Study ID Numbers  ICMJE YH16410-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yuhan Corporation
Study Sponsor  ICMJE Yuhan Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yuhan Corporation
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP