Status:
COMPLETED
Pharmacokinetic Drug Interaction Between LC15-0444 and Pioglitazone After Oral Administration in Healthy Male Subjects
Lead Sponsor:
LG Life Sciences
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The objective of the study is to investigate the drug interaction between LC15-0444 and pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and pioglitazone are admini...
Detailed Description
This study is a randomized, open-label, three-treatment, three-period, three-sequence and crossover design in healthy volunteers to evaluate tolerability, safety and pharmacokinetics after the multipl...
Eligibility Criteria
Inclusion
- Healthy male subjects between the ages of 20 and 45 years at screening
- Subjects with Body Mass Index (BMI) between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). BMI(kg/m2) = body weight(kg)/{height(m)}2.
- Subjects with fasting plasma glucose (FPG) level of 70-125 mg/dL (both inclusive) at the time of screening.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
Exclusion
- Subjects with evidence or history of clinically significant hepatic (including carrier of viral hepatitis), renal, neurologic (mood disorder, obsessive-compulsive disorder etc.), immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric disease.
- Subjects with evidence or history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or surgery (except appendectomy and herniotomy) possibly affecting drug absorption.
- Subjects with history of hypersensitivities including drug allergies (caused by aspirin, antibiotics, etc.), or history of clinically significant hypersensitivities.
- Subjects who meet the following criteria at the time of the screening examination; Serum AST(SGOT) or ALT(SGPT): \> 1.5 times upper normal limit Creatinine clearance calculated by Cockcroft-Gault equation
- \< 80 mL/min Clinical significant abnormalities on ECG including 12-lead ECG demonstrating QTc \>450 msec at screening or any rhythms except for sinus rhythm
- Subjects who show the following vital sign results at sitting position after resting for 3 min; SBP: ≤ 100 mmHg or ≥ 150 mmHg DBP: ≤ 60 mmHg or ≥ 95 mmHg
- Subjects with history of drug abuse or a positive urine result in drug screen for drug abuse or cotinine.
- Subjects who have taken any prescribed medicines or herbal medicines within 2 weeks before the first administration of the investigational product, any non-prescribed medicines or vitamin supplements within 1 week before the first administration of the investigational product. (If other conditions are satisfied, subjects may be eligible for the trial by the investigator's judgment.)
- Subjects who have participated in any other clinical trial within 2 months before the first administration of the investigational product.
- Subjects who have donated a unit of blood within 2 months or blood components within 1 month before the first administration of the investigational product.
- Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or unable to abstain from drinking throughout the trial.
- Smokers (except for those who quit smoking for at least 3 months the first administration of the investigational product)
- Subjects who take caffeine-containing or grapefruit-containing products within 3 days before the first administration of the investigational product.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01001013
Start Date
February 1 2009
End Date
December 1 2009
Last Update
December 2 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, South Korea