NCT02565368

Brief Summary

This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.5/1000 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 Jul 2015

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

July 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

1 month

First QC Date

September 23, 2015

Last Update Submit

September 30, 2015

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (2)

  • AUClast of Lobeglitazon and metformin

    Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs

  • Cmax of Lobeglitazon and metformin

    Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs

Secondary Outcomes (5)

  • AUCinf of Lobeglitazon and metformin

    Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs

  • Tmax of Lobeglitazon and metformin

    Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs

  • t1/2 of Lobeglitazon and metformin

    Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs

  • CL/F of Lobeglitazon and metformin

    Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs

  • Vd/F of Lobeglitazon and metformin

    Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs

Study Arms (2)

RT group

EXPERIMENTAL

R: Reference drug(Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mg) 1T T: Test drug(CKD-395 0.5/1000mg) 1T

Drug: Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mgDrug: CKD-395 0.5/1000mg

TR group

EXPERIMENTAL

T: Test drug(CKD-395 0.5/1000mg) 1T R: Reference drug(Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mg) 1T

Drug: Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mgDrug: CKD-395 0.5/1000mg

Interventions

Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mgDRUG

single oral administration

Also known as: Lobeglitazone Sulfate 0.5mg, Metformin HCl 1000mg
RT groupTR group
CKD-395 0.5/1000mgDRUG

single oral administration

RT groupTR group

Eligibility Criteria

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

You may qualify if:

  • Healthy man older than 19 years at the time of screening.
  • BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg
  • Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
  • Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
  • Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
  • Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.

You may not qualify if:

  • Subjects who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
  • Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
  • Subjects who show AST or AST \> 2 times upper limit of normal range.
  • Subjects who drink Alcohol \> 210g/week within 6 months prior to the screening.
  • Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
  • Subjects who show Systolic Blood Pressure ≥ 140 mmHg or Diastolic Blood Pressure ≥ 90 mmHg at screening.
  • Subjects who have history of alcohol or drug abuse, within 1 year
  • Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
  • Smoker ( ≥ 20cigarettes/day)
  • Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
  • Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing.
  • Subjects who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
  • Patients with hypersensitivity to lobeglitazone or any other thiazolidinediones ( Rosiglitazone, Rioglitazone) and to Metformin or any other biguanides
  • Patients with severe heart failure or congestive heart failure of needing drug therapy
  • Patients with liver disease
  • +12 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 Officials

  • Min-Gul Kim, MD, PhD

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

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

September 23, 2015

First Posted

October 1, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

KR(1)