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Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers

Primary Purpose

Diabetes, Hyperlipidemia

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

JLP-1310, Fasted followed by fed

JLP-1310, Fed followed by fasted

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.
Hypertension(Systolic BP ≥ 140mmHG or Diastolic BP ≥ 90mmHg), Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
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

Arm Label

JLP-1310, Fasted followed by fed

JLP-1310, Fed followed by fasted

Arm Description

JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310

Outcomes

Primary Outcome Measures

Cmax

AUC(last)

Secondary Outcome Measures

AUC(inf)

Tmax

T1/2

CL/F

Vd/F

Full Information

NCT ID

NCT02449187

First Posted

May 13, 2015

Last Updated

March 28, 2018

Sponsor

Jeil Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02449187

Brief Title

Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers

Official Title

A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

August 2, 2017 (Actual)

Primary Completion Date

September 15, 2017 (Actual)

Study Completion Date

March 9, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A randomized, open-label, single dose, crossover study to investigate the effect of food on the pharmacokinetics of 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

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

JLP-1310, Fasted followed by fed

Arm Type

Experimental

Arm Description

JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310

Arm Title

JLP-1310, Fed followed by fasted

Arm Type

Experimental

Arm Description

JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310

Intervention Type

Drug

Intervention Name(s)

JLP-1310, Fasted followed by fed

Other Intervention Name(s)

metformin hydrochloride, rosuvastatin calcium

Intervention Description

In period 1, the subjects will receive an oral pill of JLP-1310 under fasted condition. In period 2, the subjects will receive an oral pill of JLP-1310 under fed condition.

Intervention Type

Drug

Intervention Name(s)

JLP-1310, Fed followed by fasted

Other Intervention Name(s)

metformin hydrochloride, rosuvastatin calcium

Intervention Description

In period 1, the subjects will receive an oral pill of JLP-1310 under fed condition. In period 2, the subjects will receive an oral pill of JLP-1310 under fasted condition.

Primary Outcome Measure Information:

Title

Cmax

Time Frame

48 hours from baseline

Title

AUC(last)

Time Frame

48 hours from baseline

Secondary Outcome Measure Information:

Title

AUC(inf)

Time Frame

48 hours from baseline

Title

Tmax

Time Frame

48 hours from baseline

Title

T1/2

Time Frame

48 hours from baseline

Title

CL/F

Time Frame

48 hours from baseline

Title

Vd/F

Time Frame

48 hours from baseline

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

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. Hypertension(Systolic BP ≥ 140mmHG or Diastolic BP ≥ 90mmHg), Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times. 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

Sang Heon Cho, MD., Ph.D

Organizational Affiliation

Inha University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inha University Hospital

City

Incheon

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers

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