Glimepiride BE Study in Healthy Volunteers Under Fasting ConditionNCT01677247
Bioequivalence Study of 4 mg Glimepiride Tablet
A study testing Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica and Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis in people with Glimepiride BE Study in Healthy Volunteers Under Fasting Condition, run by Dexa Medica Group at 1 site in Indonesia.
Trial summary
This was a randomized, single blind, two-period, two sequence cross-over study under fasting condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test and reference formulations). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Glimepiride BE Study in Healthy Volunteers Under Fasting Condition
- What is being tested?
- Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica and Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- Feb 2011to Mar 2011
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening
- Age of 18 - 55 years
- Preferably non-smokers or moderate smokers (less than 10 cigarettes per day)
- Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study
- BMI 18 - 25 kg/m2
- Vital signs (after 10 minutes rest) must be within the following ranges:
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- SBP 100 - 120 mmHg
- DBP 60 - 80 mmHg
- Pulse rate 60 - 90 bpm
Who cannot join
- Personal/family history of allergy or hypersensitivity or contraindication to glimepiride or allied drugs
- Pregnant or lactating women
- Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illness
- Presence of any clinically significant abnormal values during screening
- Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV
- Clinically significant haematology abnormalities
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- Clinically significant electrocardiogram (ECG) abnormalities
- Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug
- Past history of anaphylaxis or angioedema
- History of drug or alcohol abuse within 12 months prior to screening
- Participation in any clinical trial within the past 90 days
- History of any bleeding or coagulative disorders
- History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm
- A donation or loss of 500 mL (or more) of blood within 3 months before this study's first dosing day
- Intake of any prescription, non-prescription drug, food supplements or herbal medicines within 14 days of this study's first dosing day
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
PT Equilab International
Jakarta, Jakarta Special Capital Region, 12430
About this study
Official title: Bioequivalence Study of Two Formulations of Glimepiride Tablet in Healthy Subjects
This was a randomized, single blind, two-period, two sequence cross-over study under fasting condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test and reference formulations).
Read the detailed description
The participating subjects were required to have an overnight fast; and in the next morning they were given orally either one tablet of 4 mg glimepiride as the test drug (produced by PT Dexa Medica) or one tablet of 4 mg glimepiride (Amaryl®, Sanofi Aventis) as the reference drug with 200 mL water.
Blood samples were drawn immediately before taking the drug (control), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 6, 9, 12, 18 and 24 hours after drug administration. Immediately after drug administration, subjects were administered 100 ml of 10% glucose at approximately 0.5, 1.5, 2, 2.5, 3.5, and 4.5 hours. In addition, 20% glucose solution was given to any subject who exhibited symptoms of hypoglycaemia. One week after the first drug administration (wash-out period), the procedure was repeated using the alternate drug.
The plasma concentrations of glimepiride were determined by high performance liquid chromatography with ultraviolet detection (HPLC-UV). The pharmacokinetic parameters assessed are AUCt, AUCinf, Cmax, tmax, and t1/2.
- Being tested
- Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica, Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis
- Keywords
- sulphonylurea, anti-hyperglycaemic, bioavailability, bioequivalence, glimepiride, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I (Test) : Glimepiride 4 mg tablet of PT Dexa MedicaDrug
In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.
Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi AventisDrug
Also called Amaryl®, manufactured by PT Sanofi Aventis
In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Test) | Experimental | Test : glimepiride 4 mg tablet of PT Dexa Medica Receives: Drug: Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica |
| Group II (Reference) | Active comparator | Reference : glimepiride (Amaryl) 4 mg tablet of PT Sanofi-Aventis, Indonesia Receives: Drug: Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability
Relative bioavailability (primarily measured by AUC and Cmax) between two glimepiride 4 mg tablet formulations (test and reference formulations) under fasting condition.
Measured: 24 hours
Secondary outcomes (2)
Bioavailability
Relative bioavailability (secondarily measured by tmax and t1/2) between two formulations of glimepiride 4 mg tablets (the Test and Reference formulations)
Measured: 24 hours
Adverse events
The presence of adverse events will be observed, reported and sufficiently handled during subjects' participation in the study (1 month).
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glimepiride BE Study in Healthy Volunteers Under Fasting ConditionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danang A. Yunaidi, MD, Principal investigator, PT Equilab International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677247
- Sponsor's protocol ID
- BE-Glimepiride
- Status last verified
- Aug 2012
- First submitted
- 29 Aug 2012
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Salem II, Idrees J, Al Tamimi JI. Determination of glimepiride in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Jan 5;799(1):103-9. doi: 10.1016/j.jchromb.2003.10.024.
PubMed 14659441Jovanovic D, Stojsic D, Zlatkovic M, Jovic-Stosic J, Jovanovic M. Bioequivalence assessment of the two brands of glimepiride tablets. Vojnosanit Pregl. 2006 Dec;63(12):1015-20. doi: 10.2298/vsp0612015j.
PubMed 17252706Malerczyk V, Badian M, Korn A, Lehr KH, Waldhausl W. Dose linearity assessment of glimepiride (Amaryl) tablets in healthy volunteers. Drug Metabol Drug Interact. 1994;11(4):341-57. doi: 10.1515/dmdi.1994.11.4.341.
PubMed 12369757
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Two Formulations of Glimepiride Tablet in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01677247
- Acronym / sponsor ID
- BE-Glimepiride
- Keywords
- sulphonylurea, anti-hyperglycaemic, bioavailability, bioequivalence, glimepiride, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 31 Aug 2012 (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.
This was a randomized, single blind, two-period, two sequence cross-over study under fasting condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test and reference formulations).
Detailed description
The participating subjects were required to have an overnight fast; and in the next morning they were given orally either one tablet of 4 mg glimepiride as the test drug (produced by PT Dexa Medica) or one tablet of 4 mg glimepiride (Amaryl®, Sanofi Aventis) as the reference drug with 200 mL water.
Blood samples were drawn immediately before taking the drug (control), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 6, 9, 12, 18 and 24 hours after drug administration. Immediately after drug administration, subjects were administered 100 ml of 10% glucose at approximately 0.5, 1.5, 2, 2.5, 3.5, and 4.5 hours. In addition, 20% glucose solution was given to any subject who exhibited symptoms of hypoglycaemia. One week after the first drug administration (wash-out period), the procedure was repeated using the alternate drug.
The plasma concentrations of glimepiride were determined by high performance liquid chromatography with ultraviolet detection (HPLC-UV). The pharmacokinetic parameters assessed are AUCt, AUCinf, Cmax, tmax, and t1/2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Test) | Experimental | Drug: Group I (Test) : Glimepiride 4 mg tablet of PT Dexa MedicaTest : glimepiride 4 mg tablet of PT Dexa Medica |
| Group II (Reference) | Active comparator | Drug: Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi AventisReference : glimepiride (Amaryl) 4 mg tablet of PT Sanofi-Aventis, Indonesia |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening
- Age of 18 - 55 years
- Preferably non-smokers or moderate smokers (less than 10 cigarettes per day)
- Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study
- BMI 18 - 25 kg/m2
Key exclusion criteria (15 listed)
- Personal/family history of allergy or hypersensitivity or contraindication to glimepiride or allied drugs
- Pregnant or lactating women
- Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illness
- Presence of any clinically significant abnormal values during screening
- Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV
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 |
|---|---|---|
| Group I (Test) : Glimepiride 4 mg tablet of PT Dexa MedicaIn each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered. | Drug | Group I (Test) |
| Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi AventisAlso: Amaryl®, manufactured by PT Sanofi AventisIn each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered. | Drug | Group II (Reference) |
Primary outcome
Bioavailability
Time frame: 24 hours
Relative bioavailability (primarily measured by AUC and Cmax) between two glimepiride 4 mg tablet formulations (test and reference formulations) under fasting condition.
2 secondary outcomes
Bioavailability
Time frame: 24 hours
Adverse events
Time frame: 1 months
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 31 Aug 2012.
- Background: PubMed 14659441Salem II, Idrees J, Al Tamimi JI. Determination of glimepiride in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Jan 5;799(1):103-9. doi: 10.1016/j.jchromb.2003.10.024.
- Background: PubMed 17252706Jovanovic D, Stojsic D, Zlatkovic M, Jovic-Stosic J, Jovanovic M. Bioequivalence assessment of the two brands of glimepiride tablets. Vojnosanit Pregl. 2006 Dec;63(12):1015-20. doi: 10.2298/vsp0612015j.
- Background: PubMed 12369757Malerczyk V, Badian M, Korn A, Lehr KH, Waldhausl W. Dose linearity assessment of glimepiride (Amaryl) tablets in healthy volunteers. Drug Metabol Drug Interact. 1994;11(4):341-57. doi: 10.1515/dmdi.1994.11.4.341.
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.
Danang A. Yunaidi, MD principal investigator
PT Equilab International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica and Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis in people with Glimepiride BE Study in Healthy Volunteers Under Fasting Condition, run by Dexa Medica Group at 1 site in Indonesia.
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 9 inclusion and 15 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 31 Aug 2012. 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 Indonesia. 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?
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?
Bioavailability (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01677247, which also lists 3 linked publications.
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 31 Aug 2012.