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 Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Groups and Cohorts

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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

Outcome Measures

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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

Eligibility Criteria

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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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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