Back to resultsThe PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers.
Primary Purpose
Diabetes, Hyperlipidemias
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
"Metformin" and "Rosuvastatin" seperately
JLP-1310
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Healthy male volunteer, age is over 19 years Body weight is over 50 kg, The result of Body Mass Index(BMI) is not less than 18.0 kg/m2 , no more than 29.0 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.
- 100 mmHg ≥ Systolic BP ≥ 150mmHg or 55 mmHg ≥ Diastolic BP ≥ 95 mmHg
- AST or ALT > X 2 UNL
- Total bilirubin > 2.0 mg/dL
- CK > X 2 UNL
- eGFR < 60 mL/min/1.73m2
- 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
- Inha University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group I
Group II
Arm Description
Period I: administration of "Metformin" and "Rosuvastatin" seperately Period II: JLP-1310
Period I: JLP-1301 Period II: administration of "Metformin' and "Rosuvastatin" seperately
Outcomes
Primary Outcome Measures
AUCt of Metformin and rosuvastatin
Cmax of Metformin and rosuvastatin
Secondary Outcome Measures
Full Information
NCT ID
NCT03690778
First Posted
September 27, 2018
Last Updated
March 27, 2019
Sponsor
Jeil Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03690778
Brief Title
The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers.
Official Title
A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 (1000/10mg) in Healthy Male Volunteers.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (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
A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hyperlipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
Period I: administration of "Metformin" and "Rosuvastatin" seperately Period II: JLP-1310
Arm Title
Group II
Arm Type
Experimental
Arm Description
Period I: JLP-1301 Period II: administration of "Metformin' and "Rosuvastatin" seperately
Intervention Type
Drug
Intervention Name(s)
"Metformin" and "Rosuvastatin" seperately
Intervention Description
administration of "Metformin" and "Rosuvastatin" seperately
Intervention Type
Drug
Intervention Name(s)
JLP-1310
Intervention Description
administration of JLP-1310
Primary Outcome Measure Information:
Title
AUCt of Metformin and rosuvastatin
Time Frame
48 hours
Title
Cmax of Metformin and rosuvastatin
Time Frame
48 hours
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 50 kg, The result of Body Mass Index(BMI) is not less than 18.0 kg/m2 , no more than 29.0 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.
100 mmHg ≥ Systolic BP ≥ 150mmHg or 55 mmHg ≥ Diastolic BP ≥ 95 mmHg
AST or ALT > X 2 UNL
Total bilirubin > 2.0 mg/dL
CK > X 2 UNL
eGFR < 60 mL/min/1.73m2
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.
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
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 Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers.
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