The Effect of Food on the Pharmacokinetic Characteristics of CKD-501

NCT01071720 | Completed Phase 1

• 1 other identifier: CKD-19HPS09L
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the effect of food on the pharmacokinetic characteristics of CKD-501 in healthy subject. And, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.

Conditions

Healthy

Keywords

Healthy subjects

Outcome Measures

Primary Outcomes (1)

• To evaluate the pharmacokinetics of CKD-501 1mg (fed vs. fasting)

  0-48 hrs

Secondary Outcomes (1)

• To evaluate the safety of CKD-501 1mg from vital signs, physical exam, ECG, laboratory test, adverse event and so on

  Throughout the trial

Study Arms (2)

CKD-501 1mg (fed-fasted group)

OTHER

CKD-501 1mg should be administered following a high-fat, high-caloric diet(fed condition) in one period and on an empty stomach(fasting condition) in the other period.

Drug: CKD-501 1mg

CKD-501 1mg (fasted-fed group)

OTHER

CKD-501 1mg should be administered on an empty stomach(fasting condition) in one period and following a high-fat, high-caloric diet(fed condition) in the other period.

Drug: CKD-501 1mg

Interventions

CKD-501 1mg DRUG

This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.

CKD-501 1mg (fasted-fed group); CKD-501 1mg (fed-fasted group)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 20 aged and 45 aged in healthy adults
• Weight more than 45kg, IBW 20% within the range
• Agreement with written informed consent

You may not qualify if:

• Subject has symptoms of acute disease within 28 days of starting administration of investigational drug
• Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) with affect the ADME of drug
• Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy disease
• Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
• Inadequate result of laboratory test
• AST(SGOT) or ALT(SGPT) \> 1.25 x upper limit of normal range
• Total bilirubin \> 1.5 x upper limit of normal range
• Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
• Subject with known for hypersensitivity reactions to glitazone
• Previously participated in other trial within 60 days
• Treatment with dug-medicated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
• Subject takes an abnormal meal which affect the ADME of drug
• Not able to taking the institutional standard meal
• Previously make whole blood donation within 60 days or component blood donation within 20 days
• Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette \> 10 cigarettes per day)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

MeSH Terms

Interventions

lobeglitazone

Study Officials

• Ji Young Park, Ph.D.

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 10, 2010

Record last verified: 2010-02