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PK Study of Telmisartan/Rosuvastatin FDC Compared to Combination of Telmisartan and Rosuvastatin

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: NCT01975961
Recruitment Status : Completed
First Posted : November 5, 2013
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Brief Summary:

This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two groups enrolling healthy adult male and female subjects under fasting conditions.

Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time.

The two treatment periods will be separated by a washout period.


Condition or disease Intervention/treatment Phase
Dyslipidemia & Hypertension Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Randomized, Open-label, Single-dose, 2-way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Telmisartan and Rosuvastatin and YH16410 in Healthy Volunteers
Study Start Date : July 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : September 2013


Arm Intervention/treatment
Experimental: FDC YH16410

Drug: Test treatment: FDC YH16410 (Telmisartan 80mg/ Rosuvastatin 20mg).

Subjects will receive single oral dose of 1 tablet of FDC containing Telmisartan 80mg and Rosuvastatin 20mg in fasted state

Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC
For co-administration, Crestor 1 tablet and Micardis 1 tablet. For FDC administration, FDC 1 tablet.

Active Comparator: Co-administration

Drug: Reference Treatment: Co-administration(Telmisartan 80mg and Rosuvastatin 20mg).

Subjects will receive 1 x Telmisartan 80mg with 1 x Rosuvastatin 20mg tablet administered orally in fasted state as a single dose

Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC
For co-administration, Crestor 1 tablet and Micardis 1 tablet. For FDC administration, FDC 1 tablet.




Primary Outcome Measures :
  1. plasma pharmacokinetic parameters for telmisartan and rosuvastatin in relevant treatments [ Time Frame: 0~72hr, 17points ]


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 18.5 and 25 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 ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 65 (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 28 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): NCT01975961


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01975961    
Other Study ID Numbers: YH16410-102
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
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