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
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ClinicalTrials.gov Identifier: NCT01195532 |
Recruitment Status
: Unknown
Verified September 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was: Recruiting
First Posted
: September 6, 2010
Last Update Posted
: September 6, 2010
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Condition or disease |
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Hyperglycemia Diabetes |
Study Type : | Observational |
Estimated Enrollment : | 40 participants |
Observational Model: | Case-Crossover |
Official Title: | 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 |
Study Start Date : | January 2010 |
Estimated Primary Completion Date : | January 2011 |
Estimated Study Completion Date : | January 2011 |
Group/Cohort |
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Gliclazide/2
60 mg*1 for T 30 mg*2 For R
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Reference and test drug
Reference: 30 mg *2 Test: 60 mg *1
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- AUC0-t, AUC0-∞, Cmax, Tmax, T1/2, and MRT in plasma will be determined with gliclazide concentrations by non-compartment methods. [ Time Frame: 10 days ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
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.
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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 Criteria:
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195532
Contact: Hsingjin E Liu, MD, PhD E Liu, MD, PhD | 8862-29307930 ext 2548 | liuxx086@yahoo.com.tw |
Taiwan | |
Taipei Medical University - Municipal Wan Fang Hospital | Recruiting |
Taipei, Taiwan, Taiwan | |
Contact: Hsingjin E Liu, MD, PhD E Liu, MD, PhD 8862-29307930 ext 2548 liuxx086@yahoo.com.tw | |
Principal Investigator: Hsingjin E Liu, MD, PhD E Liu, MD, PhD |
Principal Investigator: | Hsingjin E Liu, MD, PhD E Liu, MD, PhD | Taipei Medical University - Municipal Wan Fang Hospital |
Responsible Party: | Hsingjin E. Liu, MD, PhD., Taipei Medical University WanFang Hospital |
ClinicalTrials.gov Identifier: | NCT01195532 History of Changes |
Other Study ID Numbers: |
A29GLI60-1 E814A29E11 E814A29E11 ( Other Identifier: Rosetta ) |
First Posted: | September 6, 2010 Key Record Dates |
Last Update Posted: | September 6, 2010 |
Last Verified: | September 2010 |
Keywords provided by Taipei Medical University WanFang Hospital:
hypoglycemic drug |
Additional relevant MeSH terms:
Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases |
Gliclazide Hypoglycemic Agents Physiological Effects of Drugs |