Overview

The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers

Status:
Completed
Trial end date:
2018-01-31
Target enrollment:
0
Participant gender:
Male
Summary
A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteers
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Treatments:
Metformin
Rosuvastatin Calcium
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.

- Systolic BP > 140mmHG or Diastolic BP > 90mmHg)

- AST or ALT > X 2 UNL

- 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.