HealthyPhase 1NCT02395237

COMPOUND (INN): HOE490O - GLIMEPIRIDE / METFORMIN HCl (Amaryl® M)0 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.

A Phase 1 study testing : Amaryl® M IR 2/1000 in people with Healthy, run by Pharmaceutical Research Unit, Jordan at 1 site in Jordan.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this study is to assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl® M IR 2/1000) manufactured in… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: : Amaryl® M IR 2/1000
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: May 2015to Dec 2015
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Demography
Male subjects and female subjects of non-childbearing potential (post- menopausal or sterilized) aged 18 to 50 years inclusive.
Body weight between 50.0 and 95.0 kg, inclusive, if male, and between 40.0 and 85.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.
Health status
Certified as healthy by a comprehensive clinical assessment (detailed medical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 3 weeks prior start of the trial, registration of life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) and complete physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, Iymph nodes, skin, and neurological/psychiatric).
Normal vital signs after 10 minutes resting in supine position:

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90 mmHg < systolic blood pressure (SBP) <140 mmHg
45 mmHg < diastolic blood pressure (DBP) <90 mmHg
40 bpm < heart rate (HR) <100 bpm
Normal standard 12-lead electrocardiogram (ECG) after 10 minutes resting in supine position in the following ranges; 120 ms<PR<220 ms, QRS<120 ms, QTc≤430 ms if male, ≤450 ms if female and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however blood/serum examination creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase), and total bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper laboratory norm. For female of non-childbearing potential, sterilized at least 3 months earlier or postmenopausal i.e. artificial or natural menopause for more than 2 years with plasma FSH level > 30 UI/L.
Regulations I 07. Having given written informed consent prior to undertaking any study-related procedure.
I 08. Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
I 09. Not under any administrative or legal supervision.

Who cannot join

Medical history and clinical status E 01. Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
E 02. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
E 03. Blood donation, any volume, within 3 months before inclusion. E 04. Symptomatic hypotension, irrespective of the decrease in blood pressure. E 05. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
E 06. Major surgery of the gastrointestinal tract except for appendectomy. E 07. History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day).
E 08. Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
E 09. Excessive consumption of beverages containing xanthine bases (Pepsi/cola, tea, coffee) more than 4 cups or glasses per day) E 10. If female, pregnancy (defined as positive β-HCG test), breast-feeding. Interfering substance E 11. Medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 2 months.

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E 12. Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
General conditions E 13. Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
E 14. Any subject in the exclusion period of a previous study according to applicable regulations.
E 15. Any subject who cannot be contacted in case of emergency. E 16. Any subject who is the Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
Biological status E 17. Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
E 18. Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
E 19. Positive alcohol test. Specific to the study E 20. Any contra-indications to glimepiride, according to the applicable labeling.
E 21. Any contra-indications to metformin, according to the applicable labeling.
E 22. Use of any CYP2C9 inhibitors and/or CYP2C9 inducers within 7 days before inclusion.
E 23. Vegetarian diet E 24. Participation in another clinical trial at same time or within the preceding 3 months (calculated from the date of the final examination of the previous study),except for previous BE trials in which case 80 days are sufficient.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit
Amman, 00962

Other trials in Jordan

About this study

Official title: An Open-label, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two Batches of the Same Fixed Dose Combinations Amaryl® M IR 2/1000 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.

Read the detailed description

An open-label, randomized, two-treatment crossover bioequivalence study comparing two batches of the same fixed dose combinations Amaryl® M IR 2/1000 (glimepiride/metformin hydrochloride immediate release combination tablet) in fed conditions in healthy male and/or female subjects.

Primary Objective To assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey.

Secondary Objective(s) To assess the safety (including hypoglycemic events) of the two FDC (Amaryl® M IR 2/1000) tablets.

Up to 50 healthy subjects are to be enrolled to have 46 subjects available for the final pharmacokinetic evaluation.

Study treatment:

In each period A single dose of glimepiride/metformin HCl 2mg/1000 mg FDC (manufactured in India) Or single dose of glimepiride/metformin HCl 2mg/1000 mg FDC (manufactured in Turkey) will be administered after breakfast.

PRIMARY AND SECONDARY ENDPOINT(S)

Primary Endpoint:

Glimepiride and metformin: Cmax and AUClast

Secondary Endpoint(s):

Glimepiride and metformin: AUC0-inf, tlag, tmax and t1/2z Safety

DURATION OF STUDY (per patient) Screening : up to 15 days Treatments periods: 4 days each including treatment day Wash-out period: 4 to 7 days Follow-up: 4 to 7 days Total study duration: 37 days

Conditions: Healthy
Being tested: : Amaryl® M IR 2/1000
Keywords: Fed Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

: Amaryl® M IR 2/1000Drug

Study groups in NCT02395237
Study group	Role	What they receive
Amaryl® M IR 2/1000 (manufactured in India)	Experimental	Investigational products :Reference formulation Trade Name: Amaryl® M IR 2/1000 (manufactured in India) Dosage Form: Film coated tablet 1x1 Active Substance: Glimepiride/metformine HCl 2 mg/1000 mg Manufacturer: Goa, India Receives: Drug: : Amaryl® M IR 2/1000
Amaryl® M IR 2/1000 (manufactured in Turkey)	Experimental	Dosage form: Film coated tablet 1x1 Active substance : Glimepiride/metformine HCl 2 mg/1000 mg Manufacturer: Zentiva TR, Lüleburgaz Receives: Drug: : Amaryl® M IR 2/1000

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
Measured: 0-72
AUC0-t
Measured: 0-72

Secondary outcomes (1)

AUC0-inf
Measured: 0-72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Dec 2015

First posted23 Mar 2015 (estimated)
Study startMay 2015
Primary completionMay 2015
Study completionDec 2015

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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02395237
Sponsor's protocol ID: BEQ14393
Status last verified: Mar 2015
First submitted: 17 Mar 2015
Last updated: 18 Sep 2020
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two Batches of the Same Fixed Dose Combinations Amaryl® M IR 2/1000 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.
ClinicalTrials.gov ID: NCT02395237
Acronym / sponsor ID: BEQ14393
Conditions: Healthy
Keywords: Fed Conditions
Phase: Phase 1
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Pharmaceutical Research Unit, JordanUniversity, hospital or other
Collaborators: Sanofi
Study start: May 2015 (actual)
Primary completion: May 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 23 Mar 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.

Detailed description

Secondary Objective(s) To assess the safety (including hypoglycemic events) of the two FDC (Amaryl® M IR 2/1000) tablets.

Up to 50 healthy subjects are to be enrolled to have 46 subjects available for the final pharmacokinetic evaluation.

Study treatment:

PRIMARY AND SECONDARY ENDPOINT(S)

Primary Endpoint:

Glimepiride and metformin: Cmax and AUClast

Secondary Endpoint(s):

Glimepiride and metformin: AUC0-inf, tlag, tmax and t1/2z Safety

DURATION OF STUDY (per patient) Screening : up to 15 days Treatments periods: 4 days each including treatment day Wash-out period: 4 to 7 days Follow-up: 4 to 7 days Total study duration: 37 days

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Amaryl® M IR 2/1000 (manufactured in India)	Experimental	Drug: : Amaryl® M IR 2/1000Investigational products :Reference formulation Trade Name: Amaryl® M IR 2/1000 (manufactured in India) Dosage Form: Film coated tablet 1x1 Active Substance: Glimepiride/metformine HCl 2 mg/1000 mg Manufacturer: Goa, India
Amaryl® M IR 2/1000 (manufactured in Turkey)	Experimental	Drug: : Amaryl® M IR 2/1000Dosage form: Film coated tablet 1x1 Active substance : Glimepiride/metformine HCl 2 mg/1000 mg Manufacturer: Zentiva TR, Lüleburgaz

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Demography
Male subjects and female subjects of non-childbearing potential (post- menopausal or sterilized) aged 18 to 50 years inclusive.
Body weight between 50.0 and 95.0 kg, inclusive, if male, and between 40.0 and 85.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.
Certified as healthy by a comprehensive clinical assessment (detailed medical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 3 weeks prior start of the trial, registration of life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) and complete physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, Iymph nodes, skin, and neurological/psychiatric).
Normal vital signs after 10 minutes resting in supine position:

Key exclusion criteria (16 listed)

Medical history and clinical status E 01. Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
E 02. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
E 03. Blood donation, any volume, within 3 months before inclusion. E 04. Symptomatic hypotension, irrespective of the decrease in blood pressure. E 05. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
E 06. Major surgery of the gastrointestinal tract except for appendectomy. E 07. History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day).
E 08. Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during 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
: Amaryl® M IR 2/1000	Drug	Amaryl® M IR 2/1000 (manufactured in India), Amaryl® M IR 2/1000 (manufactured in Turkey)

Primary outcome

Cmax
Time frame: 0-72
AUC0-t
Time frame: 0-72

1 secondary outcome

AUC0-inf
Time frame: 0-72

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 18 Sep 2020.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 : Amaryl® M IR 2/1000 in people with Healthy, run by Pharmaceutical Research Unit, Jordan 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 14 inclusion and 16 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 18 Sep 2020. 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?

Cmax (time frame: 0-72). 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?

On the ClinicalTrials.gov record for NCT02395237.

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 18 Sep 2020.