Dose Proportionality Study About Amaryl M Slow Release (SR) 1/500 mg

Study Overview
=================
Brief Summary
-----------------
The pharmacokinetics of glimepiride and metformin will be compared after single dose intake of both combinations in order to answer to the following questions: Is there a dose proportionality effect between Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg? What is the safety profile of Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg?

Official Title
-----------------
An Open, Randomized, Two-Treatment, Crossover Study to Assess the Dose Proportionality of Glimepiride Between Amaryl M SR 1/500mg and 2/500mg (Glimepiride-Metformin Fixed Dose Combination Tablet) in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Amaryl M SR 1/500 mg
* Drug: Amaryl M SR 2/500 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: Between 20 to 45 years of age, inclusive (Age based on the date to give the informed consent) Ideal body weight (Broca index): between 50 to 90 kg, inclusive, and within ±20 % of Ideal Body Weight, [(Height in cm-100)×0.9] Subjects who are appropriate to participate in this study judged from clinical laboratory and physical examinations taken within 4weeks prior to the start of study Subjects who are able to abstain from caffein or caffein-containing products (e.g., coffee, cola, tea, chocolate), grapefruit and grapefruit containing products, alcohol and smoking within 72 hours before dosing and during the hospitalization Subjects who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily Exclusion Criteria: History of allergies including drug allergy, except untreated, asymptomatic, seasonal allergies at the time of dosing Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 10 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (If used medication is considered acceptable by investigator, patients can be included) History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease History of a significant surgical resection of gastrointestinal tract except appendectomy Abnormal clinical laboratory findings, especially for AST or ALT> 1.25 fold of upper normal limit Evidence of alcohol abuse (defined as regular alcohol intake that exceeds 24 oz [675 ml] of beer, 12 oz [340 ml] of wine or 160 ml of soju or 3 oz [85 ml] hard liquor [e.g., brandy, whiskey, gin] per day) or drug abuse Heavy smokers (> 10 cigarettes per day), or can't quit smoking during hospitalization Participation in clinical trials of any drug within 3 months prior to the participation of the study Donation of whole blood within 2 months or a unit of blood within 1 month prior to the start of study [Day 1]. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or HIV antibody Judged to be inappropriate for the study by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TR sequential group<br>Amaryl M SR 1/500 mg in period 1 and Amaryl M SR 2/500 mg in period 2 | Drug: Amaryl M SR 1/500 mg<br>* single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group<br>* Other names: Amaryl Mex 1/500mg, glimepiride 1mg & metformin HCl 500mg;Drug: Amaryl M SR 2/500 mg<br>* single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group<br>* Other names: Amaryl Mex 2/500mg, glimepiride 2mg & metformin HCl 500mg;|
| Active Comparator: RT sequential group<br>Amaryl M SR 2/500 mg in period 1 and Amaryl M SR 1/500 mg in period 2 | Drug: Amaryl M SR 1/500 mg<br>* single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group<br>* Other names: Amaryl Mex 1/500mg, glimepiride 1mg & metformin HCl 500mg;Drug: Amaryl M SR 2/500 mg<br>* single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group<br>* Other names: Amaryl Mex 2/500mg, glimepiride 2mg & metformin HCl 500mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast/D, Cmax/D |  | pre-dose (=1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24 hrs after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax, T1/2 |  | pre-dose (=1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24 hrs after drug administration | 
| Vital signs, ECG, physical examination, clinical laboratory tests |  | screening, treatment period 1 & 2, Post-study visit | 
| Adverse Event |  | Treatment period 1 & 2, Post-study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteer