HyperglycemiaNCT01195532
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
An observational study of Hyperglycemia and Diabetes, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Diabetes
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Health subjects
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University - Municipal Wan Fang Hospital
Taipei, Taiwan
Hsingjin E Liu, MD, PhD E Liu, MD, PhD, 8862-29307930 ext. 2548, liuxx086@yahoo.com.tw
Hsingjin E Liu, MD, PhD E Liu, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Hyperglycemia, Diabetes
- Keywords
- hypoglycemic drug
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gliclazide/2 | 60 mg*1 for T 30 mg*2 For R | |
| Reference and test drug | Reference: 30 mg *2 Test: 60 mg *1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t, AUC0-∞, Cmax, Tmax, T1/2, and MRT in plasma will be determined with gliclazide concentrations by non-compartment methods.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hsingjin E Liu, MD, PhD E Liu, MD, PhD, Principal investigator, Taipei Medical University - Municipal Wan Fang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195532
- Sponsor's protocol ID
- A29GLI60-1
- Other IDs
- E814A29E11, E814A29E11
- Status last verified
- Sep 2010
- First submitted
- 3 Sep 2010
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01195532
- Acronym / sponsor ID
- A29GLI60-1
- Conditions
- Hyperglycemia, Diabetes
- Keywords
- hypoglycemic drug
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gliclazide/2 | – | –60 mg*1 for T 30 mg*2 For R |
| Reference and test drug | – | –Reference: 30 mg *2 Test: 60 mg *1 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Health subjects
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsingjin E Liu, MD, PhD E Liu, MD, PhD principal investigator
Taipei Medical University - Municipal Wan Fang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia and Diabetes, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsingjin E Liu, MD, PhD E Liu, MD, PhD (8862-29307930 ext. 2548, liuxx086@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2010; AzTrials last refreshed its copy on 4 Nov 2026.