NCT02685774

Brief Summary

This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/500 mg in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

29 days

First QC Date

February 15, 2016

Last Update Submit

August 8, 2017

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (4)

  • AUClast of Lobeglitazone

    0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs

  • Cmax of Lobeglitazone

    0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs

  • AUClast of Metformin

    0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs

  • Cmax of Metformin

    0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs

Secondary Outcomes (10)

  • AUCinf of Lobeglitazone

    0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs

  • Tmax of Lobeglitazone

    0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs

  • 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

  • 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

  • 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

  • +5 more secondary outcomes

Study Arms (2)

RT group

OTHER

R: Reference drug(Duvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T) T: Test drug(CKD-395 0.25/500mg 2T)

Drug: Duvie Tab. 0.5mg, Glucophage XR Tab. 500mgDrug: CKD-395 0.25/500mg

TR group

OTHER

T: Test drug(CKD-395 0.25/500mg 2T) R: Reference drug(Duvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T)

Drug: Duvie Tab. 0.5mg, Glucophage XR Tab. 500mgDrug: CKD-395 0.25/500mg

Interventions

Duvie Tab. 0.5mg, Glucophage XR Tab. 500mgDRUG

Duvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T oral administration

Also known as: Duvie Tab. 0.5mg, Glucophage XR Tab. 500mg
RT groupTR group
CKD-395 0.25/500mgDRUG

CKD-395 0.25/500mg 2T oral administration

RT groupTR group

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A healthy male whose age is over 19 years old when visiting for initial screening test
  • 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
  • A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
  • 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.
  • 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.
  • The participants must have an ability and willingness to participate throughout the entire trials

You may not qualify if:

  • 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.
  • 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)
  • Who had following results after examination
  • a. ALT or AST \> twice higher than normal value
  • 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)
  • Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial
  • Whose blood pressure \> 140 mmHg (systolic blood pressure) or \> 90 mmHg (diastolic pressure)
  • Who had a medical history of alcohol and drug abuses.
  • 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
  • Who smokes more than 20 cigarettes per day
  • Who took prescribed drugs or over-the-counter drugs in 10 days before taking of very first clinical testing drug
  • 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.
  • 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.
  • 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
  • Who has a serious heart failure or a congestive heart failure that must be drug-treated
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

February 19, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

August 9, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)