Status:
COMPLETED
Dose Proportionality Study Comparing Amaryl-M 1/500 mg and Amaryl-M 2/500 mg
Lead Sponsor:
Handok Inc.
Conditions:
Healthy
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief 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) p...
Detailed Description
16 subjects were randomized to each of 2 sequence groups which have different treatment order of the study drug in each period. Only healthy volunteers had screening tests such as medical inquiry, ph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00934817
Start Date
March 1 2007
End Date
August 1 2007
Last Update
July 8 2009
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