Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers

Diabetes Mellitus, Type II Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, 2-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648854
• Other study ID #: 158BE15007
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2015
• Last updated: February 5, 2016
• Start date: October 2015
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

This study is A randomized, open-label, single dose, 2-way crossover study to investigate the effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers.

Description:

To healthy male subjects of 16, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Group 1: CKD-395 0.5/1000mg 1T(Fasting) / CKD-395 0.5/1000mg 1T(Fed) Group 2: CKD-395 0.5/1000mg 1T(Fed) / CKD-395 0.5/1000mg 1T(Fasting) Pharmacokinetic blood samples are collected up to 48hrs. Investigate the effect of food on the pharmacokinetic characteristics of CKD-395

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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, nervous, or allergic (except subclinical seasonal allergies that is not treated at injection) disease.

2. Who had a history 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%) (250mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (12%) (125 mL) = 12 g)

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

6. Whose blood pressure > 140 mmHg (systolic blood pressure) or > 90 mmHg (diastolic 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 (activation or inhibition) in 30 days before the first taking of clinical testing drug

9. Who smokes more than 20 cigarettes per day

10. Who took prescribed drugs or over-the-counter drugs 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 who can interrupt interpreting test results by having serious or chronic medical and mental status or having issues in results of the screening examination.

13. Who has a history of an extreme sensitivity of drugs that contain Rosiglitazone or drugs that have similar effect as Rosiglitazone (Pioglitazone), or drugs that contain the ingredients of Metformin or biguanidine 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 severe nephropathy

17. Who has diabetic ketoacidosis or a diabetic coma, or type 1 diabetes, or has history of acute metabolic 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. A patient who has kidney disease or renal insufficient that are caused by cardiovascular collapse (shock) and acute myocardial infarction (a male with higher serum creatinine of 1.5mg / dL, or less creatinine clearance of 80 mL / min)

21. A patient who is being tested to inject radiological iodine contrast agent into blood vessels (ex: intravenous urography, intravenous cholangiography, angiography, using contrast medium computer tomography, etc.)

22. Who has severe systematic infection or severe trauma

23. Who has nutritional status, starvation, debilitating condition, pituitary dysfunction, or adrenal insufficiency patients

24. Who has respiratory dysfunction, gastrointestinal disease

25. Who is unable to take high fat foods

26. Who cannot limit intake of grapefruit or grapefruit containing foods in 7 days from the first dosing of clinical testing drug to collect pharmacokinetic blood samples

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T
administered CKD-395 0.5/1000mg 1T to oral (fasting condition)
• CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T
administered CKD-395 0.5/1000mg 1T to oral (High fat meal fed condition)

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Deokjin-gu	Jeonju-si, Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast of Lobeglitazone		0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs	No
Primary	AUClast of Metformin		0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs	No
Primary	Cmax of Lobeglitazone		0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs	No
Primary	Cmax of Metformin		0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs	No
Secondary	AUCinf of Lobeglitazone		0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs	No
Secondary	AUCinf of Metformin		0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs	No
Secondary	Tmax of Lobeglitazone		0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs	No
Secondary	t1/2 of Lobeglitazone		0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs	No
Secondary	CL/F of Lobeglitazone		0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs	No
Secondary	Vd/F of Lobeglitazone		0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs	No
Secondary	Tmax of Metformin		0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs	No
Secondary	t1/2 of Metformin		0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs	No
Secondary	CL/F of Metformin		0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs	No
Secondary	Vd/F of Metformin		0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs	No