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

Jeil Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Diabetes; Hyperlipidemia

Treatments: Drug: JLP-1310, Fasted followed by fed; Drug: JLP-1310, Fed followed by fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT02449187

JLP-1310-102-FE

Details and patient eligibility

About

A randomized, open-label, single dose, crossover study to investigate the effect of food on the pharmacokinetics of JLP-1310 in healthy male volunteers.

Full description

A randomized, open-label, single dose, crossover clinical trial.

Enrollment: 16 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

JLP-1310, Fasted followed by fed

Experimental group

Description:

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

Treatment:

Drug: JLP-1310, Fasted followed by fed

JLP-1310, Fed followed by fasted

Experimental group

Description:

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

Treatment:

Drug: JLP-1310, Fed followed by fasted