Seoul National University Hospital
Seoul, South Korea
NCT Number: NCT00934323
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?
Looking for future studies?
Notify Me20 year–45 year
Male
Interventional
Phase 1
Seoul, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group
Other names: Amaryl Mex 1/500mg, glimepiride 1mg & metformin HCl 500mg
single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group
Other names: Amaryl Mex 2/500mg, glimepiride 2mg & metformin HCl 500mg
Time frame: 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
Time frame: 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
Time frame: screening, treatment period 1 & 2, Post-study visit
Time frame: Treatment period 1 & 2, Post-study visit
Handok Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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