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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01195532
• Other study ID #: A29GLI60-1
• Secondary ID: E814A29E11E814A2
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2010
• Last updated: September 3, 2010
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2010
• Source: Taipei Medical University WanFang Hospital
• Contact: Hsingjin E Liu, MD, PhD E Liu, MD, PhD
• Phone: 8862-29307930
• Email: liuxx086[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Case-Crossover

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

Locations

Country	Name	City	State
Taiwan	Taipei Medical University - Municipal Wan Fang Hospital	Taipei, Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t, AUC0-8, Cmax, Tmax, T1/2, and MRT in plasma will be determined with gliclazide concentrations by non-compartment methods.		10 days	No