Comparative BioavailabilityPhase 1NCT02980757
Bioequivalence Study of Gliclazide 120 mg Modified Release Tablets
A Phase 1 study testing Gliclazide 120 mg MR Tablets Formula A, Gliclazide 120 mg MR Tablets and Gliclazide 120 mg MR Tablets Formula B in people with Comparative Bioavailability, run by Disphar International B.V. at 1 site in Jordan.
Trial summary
The main purpose of this study is to assess comparative bioavailability of two test formulations of Gliclazide 120 mg Modified Release tablets (120 mg gliclazide per modified release tablet) Manufactured By Indeus Life Sciences Pvt. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparative Bioavailability
- What is being tested?
- Gliclazide 120 mg MR Tablets Formula A, Gliclazide 120 mg MR Tablets and Gliclazide 120 mg MR Tablets Formula B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJordan
- Study dates
- Jun 2014to Jun 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 50 years, inclusive
- Body Mass Index (BMI) range is within 18.5 - 30.0 Kg/m2.
- Subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs.
Who cannot join
- Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges.
- Results of laboratory tests which are outside the normal range except for HbA1c test that are outside the reference range or Hb or RBC indices with deviation outside 5% of the reference range.
- Acute infection within one week preceding first study drug administration.
- History of drug or alcohol abuse.
- Subject is a heavy smoker (more than 10 cigarettes per day).
- Subject does not agree not to take any prescription or non-prescription drugs within the two weeks preceding the first study drug administration until the end of the study.
Show all 24Show fewer
- Subject does not agree not to take any vitamins taken for nutritional purposes within two days before first study drug administration until the end of the study.
- Subject is on a special diet (for example subject is a vegetarian).
- Subject consumes large quantities of alcohol or beverages containing methylxanthines e.g. caffeine (coffee, tea, cola, chocolate etc).
- Subject does not agree not to consume any beverages or food containing alcohol 48 hours prior to study drug administration until donating the last sample in each respective period.
- Subject does not agree not to consume any beverages or food containing methyl-xanthines e.g. caffeine (coffee, tea, cola, chocolate etc.) 24 hours prior to the study drug administration until the end of confinement period.
- Subject does not agree not to consume any beverages or food containing grapefruit 7 days prior to first study drug administration until donating the last sample in the study.
- Subject has a history of severe diseases which have direct impact on the study.
- Participation in a bioequivalence study or in a clinical study within the last 80 days before first study drug administration.
- Subject intends to be hospitalized within 3 months after first study drugs administration.
- Subjects who donated blood or its derivatives in the past 3 months or who through completion of this study, would have donated more than 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.
- The subject is a pregnant female (positive urine or blood pregnancy test) or a lactating female.
- Subject has a history of significant asthma, peptic or gastric ulcer, sinusitis, pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, dermatologic or immunological disorders
- Subject who have been engaged in strenuous exercise at least one day prior to dosing till the last sample of each respective period.
- Subject having at screening examination a pulse outside the normal range of (60-100 beat per minute) or a body temperature outside the normal range of (36.4-37.7 ○C) or a respiratory rate outside the normal range of (14-20 breath per minute) or a sitting blood pressure less than 100/60 mm Hg or more than or equal to 140/90 mm Hg.
- Subject has history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption.
- Subject has a history or presence of Diabetic ketoacidosis, with or without coma, Type1 diabetes, renal insufficiency and hepatic insufficiency.
- Fasting blood sugar at screening is less than 3.33 mmol/L.
- Subject has diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Randomized, Single Dose, Three-period Crossover Open-label Study to Determine the Bioequivalence of Gliclazide 120 mg Modified Release Tablets Formula A and Gliclazide 120 mg Modified Release Tablets Formula B Manufactured by Indeus Life Sciences PVT. Ltd., Relative to DIAMICRON MR® 60 mg 2 × of Les Laboratories Servier Industrie, France, After an Oral Administration of 120 mg to Healthy Adults Under Fasting Conditions
The main purpose of this study is to assess comparative bioavailability of two test formulations of Gliclazide 120 mg Modified Release tablets (120 mg gliclazide per modified release tablet) Manufactured By Indeus Life Sciences Pvt. Ltd., Mumbai India (An Affiliate Of Disphar International B.V., The Netherlands) Relative To DIAMICRON MR® 60 mg 2 × (60 mg gliclazide per modified release tablet) Of Les Laboratories Servier Industrie, France in 15 healthy adult subjects under fasting conditions. The second aim is to asses the safety of subjects and to determine other pharmacokinetic data.
- Conditions
- Comparative Bioavailability
- Being tested
- Gliclazide 120 mg MR Tablets Formula A, Gliclazide 120 mg MR Tablets, Gliclazide 120 mg MR Tablets Formula B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gliclazide 120 mg MR Tablets Formula ADrug
Gliclazide 120 mg MR TabletsDrug
Also called DIAMICRON MR® 60 mg
Gliclazide 120 mg MR Tablets Formula BDrug
| Study group | Role | What they receive |
|---|---|---|
| Gliclazide 120 mg MR Tablets Formula A | Active comparator | Single oral dose of one tablet containing 120 mg gliclazide Receives: Drug: Gliclazide 120 mg MR Tablets Formula A |
| Gliclazide 120 mg MR Tablets Formula B | Active comparator | Single oral dose of one tablet containing 120 mg gliclazide Receives: Drug: Gliclazide 120 mg MR Tablets Formula B |
| DIAMICRON MR® 60 mg x 2 | Active comparator | Two x oral dose of one tablet containing 60 mg gliclazide Receives: Drug: Gliclazide 120 mg MR Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-t) defined as The area under the plasma concentration versus time curve, from time (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method.
Measured: Blood drawn before dosing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
Cmax defined as Max. measured plasma concentration over the time span specified.
Measured: Blood drawn before dosing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
Secondary outcomes (4)
AUC(0-inf) defined as The area under the plasma concentration versus time curve from time (0) to infinity.
Measured: Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
AUCres defined as Residual area calculated as (AUC(0-inf) - AUC(0-t)) / AUC(0-inf).
Measured: Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
tmax defined as Time of the max. measured plasma concentration. If the max. value occurs at more than one time point, tmax is defined as the first time point with this value.
Measured: Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
t1/2: The elimination or terminal half-life will be calculated as 0.693/ Kel.
Measured: Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startJun 2014
- Primary completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparative BioavailabilityStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Disphar International B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- N. Najib, Pharm. Ph.D, Study director, International Pharmaceutical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980757
- Sponsor's protocol ID
- GLI-T020
- Status last verified
- Nov 2016
- First submitted
- 20 May 2014
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized, Single Dose, Three-period Crossover Open-label Study to Determine the Bioequivalence of Gliclazide 120 mg Modified Release Tablets Formula A and Gliclazide 120 mg Modified Release Tablets Formula B Manufactured by Indeus Life Sciences PVT. Ltd., Relative to DIAMICRON MR® 60 mg 2 × of Les Laboratories Servier Industrie, France, After an Oral Administration of 120 mg to Healthy Adults Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT02980757
- Acronym / sponsor ID
- GLI-T020
- Conditions
- Comparative Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Disphar International B.V.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jun 2014 (actual)
- First posted
- 2 Dec 2016 (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 main purpose of this study is to assess comparative bioavailability of two test formulations of Gliclazide 120 mg Modified Release tablets (120 mg gliclazide per modified release tablet) Manufactured By Indeus Life Sciences Pvt. Ltd., Mumbai India (An Affiliate Of Disphar International B.V., The Netherlands) Relative To DIAMICRON MR® 60 mg 2 × (60 mg gliclazide per modified release tablet) Of Les Laboratories Servier Industrie, France in 15 healthy adult subjects under fasting conditions. The second aim is to asses the safety of subjects and to determine other pharmacokinetic data.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gliclazide 120 mg MR Tablets Formula A | Active comparator | Drug: Gliclazide 120 mg MR Tablets Formula ASingle oral dose of one tablet containing 120 mg gliclazide |
| Gliclazide 120 mg MR Tablets Formula B | Active comparator | Drug: Gliclazide 120 mg MR Tablets Formula BSingle oral dose of one tablet containing 120 mg gliclazide |
| DIAMICRON MR® 60 mg x 2 | Active comparator | Drug: Gliclazide 120 mg MR TabletsTwo x oral dose of one tablet containing 60 mg gliclazide |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 to 50 years, inclusive
- Body Mass Index (BMI) range is within 18.5 - 30.0 Kg/m2.
- Subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs.
Key exclusion criteria (24 listed)
- Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges.
- Results of laboratory tests which are outside the normal range except for HbA1c test that are outside the reference range or Hb or RBC indices with deviation outside 5% of the reference range.
- Acute infection within one week preceding first study drug administration.
- History of drug or alcohol abuse.
- Subject is a heavy smoker (more than 10 cigarettes per day).
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 |
|---|---|---|
| Gliclazide 120 mg MR Tablets Formula A | Drug | Gliclazide 120 mg MR Tablets Formula A |
| Gliclazide 120 mg MR TabletsAlso: DIAMICRON MR® 60 mg | Drug | DIAMICRON MR® 60 mg x 2 |
| Gliclazide 120 mg MR Tablets Formula B | Drug | Gliclazide 120 mg MR Tablets Formula B |
Primary outcome
AUC(0-t) defined as The area under the plasma concentration versus time curve, from time (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method.
Time frame: Blood drawn before dosing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
Cmax defined as Max. measured plasma concentration over the time span specified.
Time frame: Blood drawn before dosing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
4 secondary outcomes
AUC(0-inf) defined as The area under the plasma concentration versus time curve from time (0) to infinity.
Time frame: Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
AUCres defined as Residual area calculated as (AUC(0-inf) - AUC(0-t)) / AUC(0-inf).
Time frame: Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
tmax defined as Time of the max. measured plasma concentration. If the max. value occurs at more than one time point, tmax is defined as the first time point with this value.
Time frame: Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
t1/2: The elimination or terminal half-life will be calculated as 0.693/ Kel.
Time frame: Blood drawn before dossing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
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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.
N. Najib, Pharm. Ph.D study director
International Pharmaceutical Research Center
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 Gliclazide 120 mg MR Tablets Formula A, Gliclazide 120 mg MR Tablets and Gliclazide 120 mg MR Tablets Formula B in people with Comparative Bioavailability, run by Disphar International B.V. at 1 site in Jordan.
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 3 inclusion and 24 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: withdrawn, as of the sponsor's last update on 2 Dec 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 Jordan. 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 was withdrawn before enrolling participants, so there are no results.
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?
AUC(0-t) defined as The area under the plasma concentration versus time curve, from time (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method. (time frame: Blood drawn before dosing and at following times after the dose: 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 24, 48 and 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 2 Dec 2016.