Diabetes, Hyperlipidemia
Conditions
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.
Interventions
DRUGJLP-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.
DRUGJLP-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.
Sponsors
Jeil Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax | 48 hours from baseline |
| AUC(last) | 48 hours from baseline |
Secondary
| Measure | Time frame |
|---|---|
| Vd/F | 48 hours from baseline |
| T1/2 | 48 hours from baseline |
| Tmax | 48 hours from baseline |
| AUC(inf) | 48 hours from baseline |
| CL/F | 48 hours from baseline |
Countries
South Korea
Outcome results
None listed