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.

NCT02395237 | Withdrawn Phase 1

• 1 other identifier: BEQ14393
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Fed Conditions

Outcome Measures

Primary Outcomes (2)

• Cmax

  0-72

• AUC0-t

  0-72

Secondary Outcomes (1)

• AUC0-inf

  0-72

Study Arms (2)

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

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

Drug: : Amaryl® M IR 2/1000

Interventions

: Amaryl® M IR 2/1000 DRUG

Amaryl® M IR 2/1000 (manufactured in India); Amaryl® M IR 2/1000 (manufactured in Turkey)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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:
• mmHg \< systolic blood pressure (SBP) \<140 mmHg
• mmHg \< diastolic blood pressure (DBP) \<90 mmHg
• 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.

You may not qualify if:

• 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 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.
• 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 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 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.

Sponsors & Collaborators

• Pharmaceutical Research Unit, Jordan: lead
• Sanofi: collaborator

Study Sites (1)

Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit

Amman, 00962, Jordan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 23, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 18, 2020

Record last verified: 2015-03

Locations

JO (1)