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A Study to Investigate Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin

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ClinicalTrials.gov Identifier: NCT02951962
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Brief Summary:
This is a phase 1, open label, two-cohort, single-sequence, crossover study

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemia Drug: Twynsta 80/5mg Drug: Crestor 20mg Phase 1

Detailed Description:
This is a phase 1, open label, two-cohort, single-sequence, crossover study to investigate the pharmacokinetic drug interaction and safety of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Two-cohort, Single-Sequence, Crossover Study to Investigate the Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
Actual Study Start Date : August 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Twynsta 80/5mg
Day 1 ~ Day 9 : Twynsta 80/5mg / Day 10 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg
Drug: Twynsta 80/5mg
Hypertension
Other Name: Telmisartan/Amlodipine 80/5mg

Drug: Crestor 20mg
Hyperlipidemia
Other Name: Rosuvastatin 20mg

Experimental: Crestor 20mg
Day 1 ~ Day 5 : Crestor 20mg / Day 6 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg
Drug: Twynsta 80/5mg
Hypertension
Other Name: Telmisartan/Amlodipine 80/5mg

Drug: Crestor 20mg
Hyperlipidemia
Other Name: Rosuvastatin 20mg




Primary Outcome Measures :
  1. Telmisartan, Amlodipine, Rosuvastatin AUCτ [ Time Frame: 0 - 24 hr ]
  2. Telmisartan, Amlodipine, Rosuvastatin Cmax [ Time Frame: 0 - 24 hr ]

Secondary Outcome Measures :
  1. Telmisartan, Amlodipine, Rosuvastatin Tmax [ Time Frame: 0 - 24 hr ]
  2. Telmisartan, Amlodipine, Rosuvastatin Cmin [ Time Frame: 0 - 24 hr ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male with body mass index(BMI) between 18.5 and 28 kg/m2
  • Who has not suffered from clinically significant disease
  • Provision of signed written informed consent

Exclusion Criteria:

  • History of and clinically significant disease
  • 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 3 months prior to the first dosing
  • Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
  • Sitting blood pressure meeting the following criteria at screening: 160 ≥ systolic blood pressure ≤100 (mmHg) and 95 ≥ diastolic blood pressure ≤ 60 (mmHg)

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): NCT02951962


Locations
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Korea, Republic of
Chonbuk National University Hospital
Chunju, Korea, Republic of, 561-712
Sponsors and Collaborators
Yuhan Corporation
Investigators
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Principal Investigator: Min-Gul Kim Chonbuk National University Hospital
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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT02951962    
Other Study ID Numbers: YHP1604-101
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Telmisartan
Telmisartan amlodipine combination
Rosuvastatin Calcium
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists