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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01195532
First received: September 3, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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
Hyperglycemia
Diabetes

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources

Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gliclazide/2
60 mg*1 for T 30 mg*2 For R
Reference and test drug
Reference: 30 mg *2 Test: 60 mg *1

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

Ages Eligible for Study:   20 Years to 40 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: September 3, 2010
Last Updated: September 3, 2010
Health Authority: Taiwan: Department of Health

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013