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The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers

Primary Purpose

Diabetes, Hyperlipidemia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Metformin + Rosuvastatin
JLP-1310
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

  • 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 + Rosuvastatin Period II: JLP-1310

Period I: JLP-1301 Period II: administration of Metformin + Rosuvastatin

Outcomes

Primary Outcome Measures

AUClast of Metformin and rosuvastatin
Cmax of Metformin and rosuvastatin

Secondary Outcome Measures

Full Information

First Posted
November 30, 2016
Last Updated
March 28, 2018
Sponsor
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02982798
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 in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
January 31, 2018 (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
Detailed Description
A randomized, open-label, single dose, crossover clinical trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hyperlipidemia

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
Arm Type
Experimental
Arm Description
Period I: administration of Metformin + Rosuvastatin Period II: JLP-1310
Arm Title
Group II
Arm Type
Experimental
Arm Description
Period I: JLP-1301 Period II: administration of Metformin + Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Metformin + Rosuvastatin
Intervention Description
administration of Metformin + Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
JLP-1310
Intervention Description
administration of JLP-1310
Primary Outcome Measure Information:
Title
AUClast 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 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.
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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