Clinical trial NCT01195532: 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
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperglycemia
Diabetes
Keywords: hypoglycemic drug
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-06
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Sampling method: PROBABILITY_SAMPLE
Study population: Health subjects

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.

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 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.

Primary outcomes:
measure: AUC0-t, AUC0-∞, Cmax, Tmax, T1/2, and MRT in plasma will be determined with gliclazide concentrations by non-compartment methods.
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: Taipei Medical University - Municipal Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University - Municipal Wan Fang Hospital
name: Hsingjin E Liu, MD, PhD E Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: