Pharmacokinetic study for fixed-dose combination of pioglitazone and metformin under fed condition in healthy volunteers

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0000462
• Lead Sponsor: Chungnam National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1. Healthy male volunteers between the ages of 20 and 55 years at screening
2. Volunteers with a body weight within ± 20% of their ideal weight and over 55kg
3. Subjects have to be able to read, hear, and understand the detail of the study, and should decide to participate in the study volntarily and follow the study directions and provide written informed consent

Exclusion Criteria

1. History of hypersensitivity to pioglitazone HCl or metformin HCl
2. Volunteers with systolic blood pressure = 100 mmHg or = 150 mmHg, or diastolic blood pressure = 50 mmHg or = 145 mmHg, or with pulse rate < 45 bpm or > 100 bpm
3. Volunteers with serum creatinine = 1.5 mg/dL
4. Presence or history of cardiovascular, pulmonary, renal, endocrine, hematologic, gastrointestinal, central nervous system, psychiatric, or malignant disease
5. Volunteers with atrial and ventricular displacement, atrial fibrillation or flutter, ventricular tachycardia and ventricular fibrillation, or multifocal ventricular ectopic beats, QT interval prolongation
6. History of gastrointestinal disease or resection operation
7. History of alcohol abuse or excessive smoking, or subjects who are not willing to abstain from drinking or smoking for the duration of study
8. Use of any other investigational drugs within 3 months prior to scheduled study drug administration
9. Donation of whole blood within 2 months or any blood products within 1 month, prior to scheduled study drug administration
10. Use of drugs which are P450 inducers or inhibitors (e.g. Phenobarbital) within 1 month prior to scheduled study drug administration
11. Use of any prescription drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to scheduled study drug administration
12. Current or previous abuse of drugs or alcohol

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum concentration of pioglitazone;Area under the time-concentration curve of pioglitazone;Maximum concentration of metformin;Area under the time-concentration curve of metformin

Secondary Outcome Measures

Name	Time	Method
Time to maximum concentration of pioglitazone;Half-life of pioglitazone;Time to maximum concentration of metformin;Half-life of metformin