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

NCT ID: NCT02449187

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-02
• Study Completion Date: 2018-03-09

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.

Conditions

Diabetes; Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JLP-1310, Fasted followed by fed

JLP-1310 dosing in the fasted state followed by fed dosing

Interventions:

Drug: JLP-1310

Group Type: EXPERIMENTAL

JLP-1310, Fasted followed by fed

Intervention Type: DRUG

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.

JLP-1310, Fed followed by fasted

JLP-1310 dosing in the fasted state followed by fed dosing

Interventions:

Drug: JLP-1310

Group Type: EXPERIMENTAL

JLP-1310, Fed followed by fasted

Intervention Type: DRUG

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.

Interventions

JLP-1310, Fasted followed by fed

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

JLP-1310, Fed followed by fasted

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.

Intervention Type: DRUG

Other Intervention Names

metformin hydrochloride, rosuvastatin calcium; metformin hydrochloride, rosuvastatin calcium

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sang Heon Cho, MD., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Locations

Inha University Hospital

Incheon, , South Korea

Countries

South Korea

Other Identifiers

JLP-1310-102-FE

Identifier Type: -

Identifier Source: org_study_id