NCT02449187
Completed
Phase 1
A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- JLP-1310, Fasted followed by fed
- Conditions
- Diabetes
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- AUC(last)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male volunteer, age is over 19 years
- •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
- •Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- •Subject who has the ability and willingness to participate the whole period of trial
Exclusion Criteria
- •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.
- •Subjects who are allergic to investigational drug.
- •Subjects who have a medical history which can affect the clinical trial.
- •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.
- •History of drug abuse or positive drug screening.
- •Participation in other drug studies within 3 months prior to the drug administration.
- •Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
Arms & Interventions
JLP-1310, Fasted followed by fed
JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310
Intervention: JLP-1310, Fasted followed by fed
JLP-1310, Fed followed by fasted
JLP-1310 dosing in the fasted state followed by fed dosing Interventions: Drug: JLP-1310
Intervention: JLP-1310, Fed followed by fasted
Outcomes
Primary Outcomes
AUC(last)
Time Frame: 48 hours from baseline
Cmax
Time Frame: 48 hours from baseline
Secondary Outcomes
- 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)
Study Sites (1)
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