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The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers Volunteers

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: NCT03707899
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Jeil Pharmaceutical Co., Ltd.

Brief Summary:
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers.

Condition or disease Intervention/treatment Phase
Hypertension With Dyslipidemia Drug: JLP-1401 Drug: Telmisartan/Amlodipine, Rosuvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Adult Volunteers
Actual Study Start Date : December 13, 2018
Actual Primary Completion Date : February 18, 2019
Actual Study Completion Date : May 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (JLP-1401)
JLP-1401(Telmisartan 80 mg, amlodipine 5 mg, rosuvastatin 5 mg)
Drug: JLP-1401
Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)

Drug: Telmisartan/Amlodipine, Rosuvastatin
Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)

Active Comparator: Group II (Telmisartan/Amlodipine, Rosuvastatin)
Twinsta(Telmisartan 80 mg, amlodipine 5 mg) and Crestor(rosuvastatin 5 mg)
Drug: JLP-1401
Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)

Drug: Telmisartan/Amlodipine, Rosuvastatin
Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)




Primary Outcome Measures :
  1. AUCt [ Time Frame: 72 hr after baseline ]
    Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline

  2. Cmax [ Time Frame: 72 hr after baseline ]
    Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
  • Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
  • Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
  • Subjects who are allergic to investigational drug.
  • Subjects who have a medical history which can affect the clinical trial.
  • SBP < 90 mmHG, SBP > 140mmHG or DBP < 60 mmHG, DBP > 100mmHg
  • AST or ALT > X 2 UNL
  • CK > X 2 UNL
  • History of drug abuse or positive drug screening.
  • Participation in other drug studies within 3 months prior to the drug administration.
  • Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

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): NCT03707899


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Sponsors and Collaborators
Jeil Pharmaceutical Co., Ltd.

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Responsible Party: Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03707899    
Other Study ID Numbers: JLP-1401-102-PK
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Telmisartan
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