Clinical trial NCT00934323: Dose Proportionality Study About Amaryl M Slow Release (SR) 1/500 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: volunteer
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 33
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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?


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

Primary outcomes:
measure: AUClast/D, Cmax/D
timeFrame: 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 outcomes:
measure: Tmax, T1/2
timeFrame: 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
measure: Vital signs, ECG, physical examination, clinical laboratory tests
timeFrame: screening, treatment period 1 & 2, Post-study visit
measure: Adverse Event
timeFrame: Treatment period 1 & 2, Post-study visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin KH, Kim SE, Yoon SH, Cho JY, Jang IJ, Shin SG, Yu KS. Pharmacokinetic comparison of a new sustained-release formulation of glimepiride/metformin 1/500 mg combination tablet and a sustained-release formulation of glimepiride/metformin 2/500 mg combination tablet in healthy Korean male volunteers: a randomized, 2-sequence, 2-period, 2-treatment crossover study. Clin Ther. 2011 Nov;33(11):1809-18. doi: 10.1016/j.clinthera.2011.10.003. Epub 2011 Oct 27.