None listed
Conditions
Interventions
Intervention1: Glimepiride Oral Disintegration Strip 1 mg: One orally disintegrating strip will be administered orally at scheduled dosing time in sitting posture
Control Intervention1: Amaryl (glimep
Sponsors
Sanofi Healthcare India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy male literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50 - 24.9 Kg/m2 and with weight minimum of 45 kg. - Healthy volunteers as evaluated by medical history, vitals and general clinical examination. - Normal or clinically insignificant biochemical, hematological, urine and serology parameters. - Non-smokers as evident from the history obtained will be included - Normal or clinically insignificant ECG. - Negative urine test for drugs of abuse, alcohol breath analysis. - Subjects having calculated eGFR value at the time of screening >= 60 ml/min â?? period. - Volunteers who are willing to use acceptable methods of contraception. - Volunteers who can give written informed consent and communicate effectively.
Exclusion criteria
Exclusion criteria: - History of any major surgical procedure in the past 03 months. - Subjects with intolerance to lactose, fructose or galactose. - History or presence of asthma, urticaria or other significant allergic reactions. - History or presence of significant recent trauma. - History or presence of cancer or basal or squamous cell carcinoma. - Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/ immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant disease as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking the medication. - History of chronic alcoholism/ chronic smoking/ drug of abuse. - Volunteers with known hypersensitivity to Glimepiride or any of the excipients. - History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing - Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV1&2) antibodies. - Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Glimepiride or any other medication judged to be clinically significant by the investigator. - History of consumption of grapefruit and/or its products within 10 days prior to the start of study. - Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in. - History of consumption of one or more of the below, 48 hours prior to dosing: - Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator. - Volunteers who are dysphagic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the relative bioavailability of Glimepiride Oral Disintegration Strip 1 mg (Test) versus Amaryl Tablet 1 mg (Comparator) after single oral administration under fed conditionsTimepoint: 00.00 (Pre-dose), 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, and 36.00 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective: â?¢ Additional PK parameters for Glimepiride â?¢ Safety assessment of test and comparator formulations Secondary PK parameters: Tmax, T1/2 (terminal half-life), Kel and AUC_%Extrap_obs.Timepoint: 00.00 (Pre-dose), 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, and 36.00 hours post dose | — |
Countries
India
Contacts
Public ContactMr. Premnath L
Sanofi Healthcare India Private Limited
Outcome results
None listed