Overview

CKD-396 Drug-drug Interaction Study(A) (CKD-396 DDI(A) P1)

Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and sitagliptin in healthy male volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Treatments:
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

1. A healthy male whose age is over 19 years old when visiting for initial screening test

2. Body mass index(BMI) between 17.5~30.5 kg/m^2 and the body weight must be over 55kg
(Body mass index (BMI) = weight (kg) / height (m)^2)

3. A male with no congenital or chronic disease in three years, no history of symptoms in
internal treatment, or no knowledge in the area

4. Due to the special characteristics of drugs, the participators must be qualified to do
the clinical screening after examined through hematology test and blood chemistry
analysis, urinary test, the electrocardiogram (ECG), and etc.

5. The participants must be volunteered and sign in an informed consent document proven
by Chonbuk National University IRB before joining a study to show that he was given
informed the purpose of tests and the special characteristics of drugs.

6. The participants must have an ability and willingness to participate throughout the
entire trials

Exclusion Criteria:

1. A person who had a history or symptoms of clinically aware of blood, kidney, internal
secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nercous,
or allergic(except subclinical seasonal allergies that is not treated at injecion)
desease.

2. Who had a gistory of gastrointestinal related disease which can be affected the drug
absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's
disease) or surgeries (except a simple appendectomy or herniotomy)

3. Who had following results after examination

a. ALT or AST > twice higher than normal value

4. Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup
of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (!2%)
(125 mL) = 12g)

5. Who participated other clinical test or took testing bioequivalence drugs in 3 months
before the first clinical drug trial.

6. Whose blood pressure ≤ 100 or ≥150(systolic blood pressure) or < 60 or ≥ 100(diastolic
blood pressure)

7. Who had a medical history of alcohol and drug abuses.

8. Who had taken a drug that has a control of metabolic rate (activatioh or inhibithion)
in 30 days before the first taking of clinical testing durg.

9. WHo smokes more than 20 eigarettes per day.

10. Who took prescribed drugs or over-the-conuter durgs in 10 days before taking of very
first clinical testing drug.

11. Who participated in whole blood donation in 2 months before the first taking of
clinical testing drugs or platelet donations in 1 month before the first taking to
clinical testing drugs.

12. Who has a potent to increase a danger by participating in the clinical trials or sho
can interrupt interpretin test results by having serious or chronic medical and mental
status or having issues in results of the screening examination.

13. Who has a histroy of an extreme sensitivity of drugs that contain Rosiglitazone or
dugs that have similar effect a Rosiglitazone(Pioglitazone), or drugs that contain the
ingredients of Sitagliptin or thiazolidinediones drugs.

14. Who has a serious heart failure or a congestive heart failure that must be
drug-treated

15. A patient with hepatopathy.

16. A patient with wevere nephropathy.

17. Who has diabetic ketoacidosis or a diaetic coma, or type 1 diabetes, or has history of
acute metablic acidosis or ketoacidosis.

18. A patient with serious infectious disease or severe injuries before and after a
surgery.

19. Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose
malabsorption or genetic disorders.

20. Test subjects who is not willing or unable to comply with guidelines described in this
protocol.

21. A person who is not determined unsuitable to participate in this test by the
researchers.