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

Phase 1

Completed

• Conditions: Diabetes; Hyperlipidemia
• Interventions: Drug: JLP-1310, Fasted followed by fed; Drug: JLP-1310, Fed followed by fasted

• Registration Number: NCT02449187
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-17
• Study First Posted: 2015-05-20
• Study Start: 2017-08-02
• Primary Completion: 2017-09-15
• Status Verified: 2018-03
• Study Completion: 2018-03-09
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

1. Healthy male volunteer, age is over 19 years
2. 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
3. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
4. Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria

1. 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.
2. Subjects who are allergic to investigational drug.
3. Subjects who have a medical history which can affect the clinical trial.
4. 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.
5. History of drug abuse or positive drug screening.
6. Participation in other drug studies within 3 months prior to the drug administration.
7. Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
JLP-1310, Fasted followed by fed	JLP-1310, Fasted followed by fed	JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310
JLP-1310, Fed followed by fasted	JLP-1310, Fed followed by fasted	JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310

Primary Outcome Measures

Name	Time	Method
AUC(last)	48 hours from baseline
Cmax	48 hours from baseline

Secondary Outcome Measures

Name	Time	Method
AUC(inf)	48 hours from baseline
Tmax	48 hours from baseline
T1/2	48 hours from baseline
CL/F	48 hours from baseline
Vd/F	48 hours from baseline

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of