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

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

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 Overview

• Status: Completed
• Conditions: Diabetes; Hyperlipidemia
• Intervention / Treatment: Drug: JLP-1310, Fasted followed by fed; Drug: JLP-1310, Fed followed by fasted

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Inha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JLP-1310, Fasted followed by fed; JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310	Drug: 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.; Other Names: metformin hydrochloride, rosuvastatin calcium
Experimental: JLP-1310, Fed followed by fasted; JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310	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.; Other Names: metformin hydrochloride, rosuvastatin calcium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax	48 hours from baseline
AUC(last)	48 hours from baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Sang Heon Cho, MD., Ph.D, Inha University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): March 9, 2018

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 17, 2015
• First Posted (Estimate): May 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Rosuvastatin Calcium; Calcium; Metformin; Calcium, Dietary
• Other Study ID Numbers: JLP-1310-102-FE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No