A randomized, open-label, single dose, crossover study to investigate the effect of food on the pharmacokinetics of JLP-1310 in healthy male volunteers
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001497
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 16
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
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).
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUClast of Metformin, Rosuvastatin
- Secondary Outcome Measures
Name Time Method AUCinf, Tmax, t1/2, CL/F, Vd/F of Metformin, rosuvastatin