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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.

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ClinicalTrials.gov Identifier: NCT02395237
Recruitment Status : Withdrawn
First Posted : March 23, 2015
Last Update Posted : September 18, 2020
Sponsor:
Collaborator:
Sanofi-aventis Liban SAL
Information provided by (Responsible Party):
Pharmaceutical Research Unit, Jordan

Brief 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 India and in Turkey.

Condition or disease Intervention/treatment Phase
Healthy Drug: : Amaryl® M IR 2/1000 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Glimepiride

Arm Intervention/treatment
Experimental: Amaryl® M IR 2/1000 (manufactured in India)
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
Drug: : Amaryl® M IR 2/1000
Experimental: Amaryl® M IR 2/1000 (manufactured in Turkey)
Dosage form: Film coated tablet 1x1 Active substance : Glimepiride/metformine HCl 2 mg/1000 mg Manufacturer: Zentiva TR, Lüleburgaz
Drug: : Amaryl® M IR 2/1000



Primary Outcome Measures :
  1. Cmax [ Time Frame: 0-72 ]
  2. AUC0-t [ Time Frame: 0-72 ]

Secondary Outcome Measures :
  1. AUC0-inf [ Time Frame: 0-72 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Demography

  1. Male subjects and female subjects of non-childbearing potential (post- menopausal or sterilized) aged 18 to 50 years inclusive.
  2. 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
  3. 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).
  4. Normal vital signs after 10 minutes resting in supine position:

    • 90 mmHg < systolic blood pressure (SBP) <140 mmHg
    • 45 mmHg < diastolic blood pressure (DBP) <90 mmHg
    • 40 bpm < heart rate (HR) <100 bpm
  5. 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.
  6. 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.

Exclusion Criteria:

  • 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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395237


Locations
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Jordan
Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit
Amman, Jordan, 00962
Sponsors and Collaborators
Pharmaceutical Research Unit, Jordan
Sanofi-aventis Liban SAL
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Responsible Party: Pharmaceutical Research Unit, Jordan
ClinicalTrials.gov Identifier: NCT02395237    
Other Study ID Numbers: BEQ14393
First Posted: March 23, 2015    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: March 2015
Keywords provided by Pharmaceutical Research Unit, Jordan:
Fed Conditions
Additional relevant MeSH terms:
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Disease
Pathologic Processes
Glimepiride
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors