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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
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital

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.

Condition or disease
Hyperglycemia Diabetes

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.

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
Gliclazide/2
60 mg*1 for T 30 mg*2 For R
Reference and test drug
Reference: 30 mg *2 Test: 60 mg *1



Primary Outcome Measures :
  1. 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
Plasma


Information from the National Library of Medicine

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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
Study Population
Health subjects
Criteria

Inclusion Criteria:

Subjects will be enrolled into the study according to the following criteria:

  1. 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.
  2. 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.

  3. Body weight must be greater than 50 kg and within -20 to +20% of ideal body weight.
  4. Able to sign informed consent prior to study.
  5. 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:

  1. Use of any prescription medication within 14 days prior to dosing.
  2. Use of over-the-counter medications or vitamins within 14 days prior to dosing.
  3. Significant illness within 2 weeks prior to dosing.
  4. Participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation.
  5. Donate or loss more than 500 mL of blood within 3 months prior to dosing.
  6. Presence of cardiovascular disease.
  7. Presence of gastrointestinal disease.
  8. Presence of asthma or lung disease.
  9. 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.
  10. Presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria).
  11. Presence of neurological disease.
  12. Presence of psychiatrical disease.
  13. Subject is known for HIV infected.
  14. A known hypersensitivity to gliclazide or its analogs.
  15. History of drug or alcohol abuse within 12 months prior to dosing.
  16. Permanent confinement to an institution.
  17. Individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons.

Information from the National Library of Medicine

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


Contacts
Contact: Hsingjin E Liu, MD, PhD E Liu, MD, PhD 8862-29307930 ext 2548 liuxx086@yahoo.com.tw

Locations
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         
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
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