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

NCT ID: NCT03247140

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-10

Study Completion Date

2017-11-27

Brief Summary

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

Detailed Description

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Conditions

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Hypertension With Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I (JLP-1401)

JLP-1401(Telmisartan 80 mg, amlodipine 10 mg, rosuvastatin 20 mg)

Group Type EXPERIMENTAL

JLP-1401

Intervention Type DRUG

Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)

Telmisartan/Amlodipine, Rosuvastatin

Intervention Type DRUG

Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)

Group II(Telmisartan/Amlodipine, Rosuvastatin)

Twinsta(Telmisartan 40 mg, amlodipine 5 mg) 2 tab and Crestor(rosuvastatin 20 mg)

Group Type EXPERIMENTAL

JLP-1401

Intervention Type DRUG

Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)

Telmisartan/Amlodipine, Rosuvastatin

Intervention Type DRUG

Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)

Interventions

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JLP-1401

Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)

Intervention Type DRUG

Telmisartan/Amlodipine, Rosuvastatin

Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)

Intervention Type DRUG

Eligibility Criteria

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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.
* Systolic BP \> 140mmHG or Diastolic BP \> 90mmHg)
* AST or ALT \> 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.
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Gul Kim, MD., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JLP-1401-101-PK

Identifier Type: -

Identifier Source: org_study_id