Status:
UNKNOWN
An Open-randomized, Balanced, Crossover Bioequivalence Study to Compare One MR Tablet of 60 mg Gliclazide and Two MR Tablets of 30 mg Gliclazide in Healthy Subjects
Lead Sponsor:
Taipei Medical University WanFang Hospital
Conditions:
Hyperglycemia
Diabetes
Eligibility:
MALE
20-40 years
Brief Summary
The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different MR tablets of gliclazide after single oral administration at the same doses to healthy subjects.
Detailed Description
The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different MR tablets of gliclazide after single oral administration at the same doses to healthy subjects.
Eligibility Criteria
Inclusion
- Subjects will be enrolled into the study according to the following criteria:
- Subjects must be male at the age of 20-40 years old in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
- Vital signs (after 3 minutes resting in a upright position) which are within the following ranges:
- Ear body temperature between 35.0-37.5 °C. Systolic blood pressure, 90-140 mm Hg. Diastolic blood pressure, 50-90 mm Hg. Pulse rate, 50-90 bpm. Fasting blood glucose, \< 100 mg/dL.
- Body weight must be greater than 50 kg and within -20 to +20% of ideal body weight.
- Able to sign informed consent prior to study.
- Able to communicate well with the investigator and comply with the requirements of the study.
Exclusion
- Subjects meet any of the following criteria during pre-study examination evaluation will be excluded from entry into or continuation in the study:
- Use of any prescription medication within 14 days prior to dosing.
- Use of over-the-counter medications or vitamins within 14 days prior to dosing.
- Significant illness within 2 weeks prior to dosing.
- Participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation.
- Donate or loss more than 500 mL of blood within 3 months prior to dosing.
- Presence of cardiovascular disease.
- Presence of gastrointestinal disease.
- Presence of asthma or lung disease.
- Presence of liver disease, hepatitis B, hepatitis C or liver injury as indicated by an abnormal liver function profile such as GOT, GPT,gama-GT, alkaline phosphatase, serum bilirubin, HBsAg, or Anti-HCV.
- Presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria).
- Presence of neurological disease.
- Presence of psychiatrical disease.
- Subject is known for HIV infected.
- A known hypersensitivity to gliclazide or its analogs.
- History of drug or alcohol abuse within 12 months prior to dosing.
- Permanent confinement to an institution.
- Individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01195532
Start Date
January 1 2010
End Date
January 1 2011
Last Update
September 6 2010
Active Locations (1)
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1
Taipei Medical University - Municipal Wan Fang Hospital
Taipei, Taiwan, Taiwan