Back to resultsThe PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers
Primary Purpose
Hypertension With Dyslipidemia
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JLP-1401
Telmisartan/Amlodipine, Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension With Dyslipidemia
Eligibility 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.
- 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.
Sites / Locations
- Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group I (JLP-1401)
Group II(Telmisartan/Amlodipine, Rosuvastatin)
Arm Description
JLP-1401(Telmisartan 80 mg, amlodipine 10 mg, rosuvastatin 20 mg)
Twinsta(Telmisartan 40 mg, amlodipine 5 mg) 2 tab and Crestor(rosuvastatin 20 mg)
Outcomes
Primary Outcome Measures
AUC
Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Cmax
Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT03247140
First Posted
July 28, 2017
Last Updated
December 21, 2017
Sponsor
Jeil Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03247140
Brief Title
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers
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 Coadministration of Rosuvastatin and Telmisartan/Amlodipine in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 10, 2017 (Actual)
Primary Completion Date
August 7, 2017 (Actual)
Study Completion Date
November 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jeil Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension With Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (JLP-1401)
Arm Type
Experimental
Arm Description
JLP-1401(Telmisartan 80 mg, amlodipine 10 mg, rosuvastatin 20 mg)
Arm Title
Group II(Telmisartan/Amlodipine, Rosuvastatin)
Arm Type
Experimental
Arm Description
Twinsta(Telmisartan 40 mg, amlodipine 5 mg) 2 tab and Crestor(rosuvastatin 20 mg)
Intervention Type
Drug
Intervention Name(s)
JLP-1401
Intervention Description
Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)
Intervention Type
Drug
Intervention Name(s)
Telmisartan/Amlodipine, Rosuvastatin
Intervention Description
Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)
Primary Outcome Measure Information:
Title
AUC
Description
Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Time Frame
72hr after baseline
Title
Cmax
Description
Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Time Frame
72 after baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Gul Kim, MD., Ph.D
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers
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