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

A Ranomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a 16.53 mg Pioglitazone HCl/500 mg Metformin HCl Extended Release Tablet Compared with a 16.53 mg Pioglitazone Tablet and 500 mg Metformin HCl Extended Release Tablets under Fed Conditions in Healthy Male Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000462

Enrollment

Registered

2012-06-25

Start date

2012-04-25

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Test group: oral administration of 1 tablet of DMPMet XR 15/500 mg under fed condition Reference group: oral administration of 1 tablet of Actos 15 mg and 1 tablet of Diabex XR 500 mg under fed

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Time to maximum concentration of pioglitazone;Half-life of pioglitazone;Time to maximum concentration of metformin;Half-life of metformin	—

Countries

Korea, Republic of

Contacts

Public ContactJaeWoo Kim

Chungnam National University Hospital

Outcome results