Dose Proportionality Study Comparing Amaryl-M 1/500 mg and Amaryl-M 2/500 mg

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The pharmacokinetics of glimepiride and metformin HCl will be compared after single dose intake of both combinations in order to answer the following questions:

• Is Amaryl-M 1/500 mg (Test tablet) proportional to Amaryl-M 2/500 mg tablet with regard to the glimepiride component?

• Is Amaryl-M 1/500 mg (Test tablet) tolerable comparing with Amaryl-M 2/500 mg?

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Handok Inc.; Handok Pharmaceuticals Co., Ltd.
• Treatments: Glimepiride; Metformin

Criteria

Inclusion Criteria:

• Age: Between 19 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 caffeine or caffeine-containing products (e.g., coffee, cola, tea, chocolate), grapefruit and grapefruit containing products, alcohol and smoking within 7 days before dosing and during the hospitalization

• Subjects who give their informed consent voluntarily to participate in the study

Exclusion Criteria:

• History of allergies including drug allergy, except untreated, asymptomatic, seasonal allergies at the time of dosing

• Use any medication not considered acceptable by the clinical investigator during the last 10 days period before the start day of the study

• Use of any inducer or inhibitors of metabolizing enzymes during the last 28 days before the start day of the study.

• 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, total bilirubin > 1.5 fold of upper normal level

• Pregnant or lactating woman or woman of childbearing potential without medically acceptable birth control during the study

• 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 per day [e.g., brandy, whiskey, gin]) 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 start of study

• Donation of 200ml of whole blood within 4 weeks or 400ml within 12 weeks prior to the start of study

• Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or HIV antibody

• Judged to be inappropriate for the study by the investigator