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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)

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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

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer
Study Start Date : November 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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.





Primary Outcome Measures :
  1. AUC [ Time Frame: 72hr ]
    AUC τ,ss of Rosuvastatin and Telmisartan

  2. Cmax [ Time Frame: 72hr ]
    Cmax,ss of Rosuvastatin and Telmisartan


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992601


Locations
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Korea, Republic of
Severance Hospital, Yonsei University
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yuhan Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01992601    
Other Study ID Numbers: YH16410-101
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Yuhan Corporation:
Drug interaction
Rosuvastatin
Telmisartan
Pharmacokinetic
(Pharmacokinetics and Drug Interaction)
Additional relevant MeSH terms:
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Telmisartan
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists