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OpenTrials
Completed

NCT Number: NCT01992601

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

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.

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital, Yonsei University

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female aged 20 to 50 with a body mass index(BMI) between 19 and 27 kg/m2
  • Acceptable medical history, physical examination, laboratory tests and EKG, during screening
  • 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.

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

Treatment and study plan

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

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.

Primary outcomes

  1. AUC

    Time frame: 72hr

    AUC τ,ss of Rosuvastatin and Telmisartan

  2. Cmax

    Time frame: 72hr

    Cmax,ss of Rosuvastatin and Telmisartan

Secondary outcomes

  1. AUC

    Time frame: 72hr

    AUC last,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan

  2. AUC

    Time frame: 72hr

    AUC inf,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan

  3. Tmax

    Time frame: 72hr

    Tmax,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan

  4. t1/2

    Time frame: 72hr

    t1/2 of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan

  5. Cmin

    Time frame: 72hr

    Cmin,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan

  6. AUC

    Time frame: 72hr

    AUCτ,ss of N-desmetyl Rosuvastatin

  7. Cmax

    Time frame: 72hr

    Cmax,ss of N-desmetyl Rosuvastatin

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Acronym: YH16410 DDI

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Nov 25, 2013
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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