HealthyPhase 1NCT02643329
Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations
A Phase 1 study testing BF-Gliclazide Tablet 80mg and Diamicron 80mg Tablet in people with Healthy, run by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited at 1 site in Hong Kong.
Trial summary
The purpose of the study is to compare the bioavailability of a generic product of gliclazide (Product Name: BF-Gliclazide Tablet 80mg, Manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited) with that of reference product (Product Name: Diamicron 80mg Tablet… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BF-Gliclazide Tablet 80mg and Diamicron 80mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2016to Apr 2016
- Phase
- Phase 1
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index between 18 to 27
- Accessible vein for blood sampling
- High probability for compliance and completion of the study
- No significant abnormalities in general physical examination
- ECG recording within normal limits
- Biochemical and haematological parameters within normal limits
- Subjects must agree to take effective contraceptive methods to prevent his partner from becoming pregnant during the time of first dose of study medication until one week of last dose administration
Who cannot join
- History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
- Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test
- Tabacco use in any forms
- Regular consumer of alcohol
- Blood donation within 4 weeks prior to the start of the study
- Use of gliclazide within 4 weeks before the study
Show all 10Show fewer
- Use of antidiabetic medications within 4 weeks before the study
- Volunteer in any other clinical drug study within 2 months prior to this study
- Hypersensitivity to gliclazide or other drugs in its class
- History of drug abude in any form
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong
New Territories
About this study
The purpose of the study is to compare the bioavailability of a generic product of gliclazide (Product Name: BF-Gliclazide Tablet 80mg, Manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited) with that of reference product (Product Name: Diamicron 80mg Tablet, Manufactured by Les Laboratoires Servier Industrie, France) when administered to healthy volunteers under fasting conditions. The plasma pharmacokinetic data of gliclazide obtained from two formulations will be used to access the interchangeability of the products.
Read the detailed description
The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of one to two weeks. During each study session, healthy male subjects will be administered a single oral dose of 80 mg gliclazide (one BF-Gliclazide Tablet 80 mg or one Diamicron 80 mg Tablet) after an overnight fast of approximately 10 hours. 20% glucose will be given orally to each subject at 2 h after drug administration to minimize the risk of hypoglycaemia. Venous blood samples will be collected at pre-dose (0 h) and up to 72 hours post-dose. The plasma concentrations of gliclazide will be determined by a validated assay. The non-compartmental method will be used to analyze the plasma concentration-time data and calculate the main pharmacokinetic parameters such as Cmax, Tmax, AUC0-last, AUC0-inf and T1/2. ANOVA will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf. The two one-sided tests will be used to calculate the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax, and to assess the bioequivalence of the two products.
- Conditions
- Healthy
- Being tested
- BF-Gliclazide Tablet 80mg, Diamicron 80mg Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BF-Gliclazide Tablet 80mgDrug
Also called Gliclazide Tablet 80mg
BF-Gliclazide Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Diamicron 80mg TabletDrug
Also called Gliclazide Tablet 80mg
Diamicron 80mg Tablet is manufactured by Les Laboratoires Servier Industrie, France
| Study group | Role | What they receive |
|---|---|---|
| BF-Gliclazide Tablet 80mg | Experimental | During the study session, healthy male subjects will be administered a single oral dose of BF-Gliclazide Tablet 80 mg after an overnight fast of approximately 10 hours. Receives: Drug: BF-Gliclazide Tablet 80mg |
| Diamicron 80mg Tablet | Active comparator | During the study session, healthy male subjects will be administered a single oral dose of Diamicron 80 mg Tablet after an overnight fast of approximately 10 hours. Receives: Drug: Diamicron 80mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of gliclazide
Measured: 72 hours
Area under the plasma concentration versus time curve (AUC) of gliclazide
Measured: 72 hours
Secondary outcomes (2)
Time to maximum concentration (Tmax) of gliclazide
Measured: 72 hours
Elimination half-life (t1/2) of gliclazide
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Vincent HL Lee, Principal investigator, School of Pharmacy, The Chinese Univesity of Hong KongRisa Ozaki, Study director, Phase 1 Clinical Trial Centre, The Chinese University of Hong KongBrian Tomlinson, Study director, Dept. of Medicine and Therapeutics, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643329
- Sponsor's protocol ID
- BABE-P14-095
- Status last verified
- Jul 2016
- First submitted
- 28 Dec 2015
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Study investigators and his/her study team members, domestic and foreign regulatory agencies, the IRB/EC involved in the study, healthcare providers who provide services to subjects in connection with this study, and laboratories and other individuals and organizations that analyze the subjects' protected health information in connection with this study have access to the data or study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations
- ClinicalTrials.gov ID
- NCT02643329
- Acronym / sponsor ID
- BABE-P14-095
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 31 Dec 2015 (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 purpose of the study is to compare the bioavailability of a generic product of gliclazide (Product Name: BF-Gliclazide Tablet 80mg, Manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited) with that of reference product (Product Name: Diamicron 80mg Tablet, Manufactured by Les Laboratoires Servier Industrie, France) when administered to healthy volunteers under fasting conditions. The plasma pharmacokinetic data of gliclazide obtained from two formulations will be used to access the interchangeability of the products.
Detailed description
The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of one to two weeks. During each study session, healthy male subjects will be administered a single oral dose of 80 mg gliclazide (one BF-Gliclazide Tablet 80 mg or one Diamicron 80 mg Tablet) after an overnight fast of approximately 10 hours. 20% glucose will be given orally to each subject at 2 h after drug administration to minimize the risk of hypoglycaemia. Venous blood samples will be collected at pre-dose (0 h) and up to 72 hours post-dose. The plasma concentrations of gliclazide will be determined by a validated assay. The non-compartmental method will be used to analyze the plasma concentration-time data and calculate the main pharmacokinetic parameters such as Cmax, Tmax, AUC0-last, AUC0-inf and T1/2. ANOVA will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf. The two one-sided tests will be used to calculate the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax, and to assess the bioequivalence of the two products.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BF-Gliclazide Tablet 80mg | Experimental | Drug: BF-Gliclazide Tablet 80mgDuring the study session, healthy male subjects will be administered a single oral dose of BF-Gliclazide Tablet 80 mg after an overnight fast of approximately 10 hours. |
| Diamicron 80mg Tablet | Active comparator | Drug: Diamicron 80mg TabletDuring the study session, healthy male subjects will be administered a single oral dose of Diamicron 80 mg Tablet after an overnight fast of approximately 10 hours. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body Mass Index between 18 to 27
- Accessible vein for blood sampling
- High probability for compliance and completion of the study
- No significant abnormalities in general physical examination
- ECG recording within normal limits
Key exclusion criteria (10 listed)
- History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
- Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test
- Tabacco use in any forms
- Regular consumer of alcohol
- Blood donation within 4 weeks prior to the start of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BF-Gliclazide Tablet 80mgAlso: Gliclazide Tablet 80mgBF-Gliclazide Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited | Drug | BF-Gliclazide Tablet 80mg |
| Diamicron 80mg TabletAlso: Gliclazide Tablet 80mgDiamicron 80mg Tablet is manufactured by Les Laboratoires Servier Industrie, France | Drug | Diamicron 80mg Tablet |
Primary outcome
Peak plasma concentration (Cmax) of gliclazide
Time frame: 72 hours
Area under the plasma concentration versus time curve (AUC) of gliclazide
Time frame: 72 hours
2 secondary outcomes
Time to maximum concentration (Tmax) of gliclazide
Time frame: 72 hours
Elimination half-life (t1/2) of gliclazide
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Individual participant dataSharing planned: No. Study investigators and his/her study team members, domestic and foreign regulatory agencies, the IRB/EC involved in the study, healthcare providers who provide services to subjects in connection with this study, and laboratories and other individuals and organizations that analyze the subjects' protected health information in connection with this study have access to the data or study.
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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.
Vincent HL Lee principal investigator
School of Pharmacy, The Chinese Univesity of Hong Kong
Risa Ozaki study director
Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong
Brian Tomlinson study director
Dept. of Medicine and Therapeutics, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BF-Gliclazide Tablet 80mg and Diamicron 80mg Tablet in people with Healthy, run by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited at 1 site in Hong Kong.
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 10 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: finished, as of the sponsor's last update on 25 Jul 2016. 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 Hong Kong. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plasma concentration (Cmax) of gliclazide (time frame: 72 hours). The study lists 2 primary outcomes in all. 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 25 Jul 2016.