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. The completion date has passed and the status has not been verified in more than two years.

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

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 ]

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 mg1 for T 30 mg2 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 (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:

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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 )
Study First Received:	September 3, 2010
Last Updated:	September 3, 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

ClinicalTrials.gov processed this record on June 26, 2017

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