This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women
Pharmacokinetics of a single Oral Dose of Maxmarvil® in healthy postmenopausal women without a previous history of fractures 1. evaluation of Pharmacokinetics * Urine collection : Pre-dose(pre 1hour), post-dose 0\~6 hour, 6\~12 hour, 12\~24 hour * Evaluation Variables : Aet 2. Evaluation of safety, pharmacodynamics * Adverse Event : check it every and frequently * Physical exam : screening, just before injection, post-dose 24 hour and post-study visit * Vital sign : screening, just before injection, post-dose 1 hour, 24 hour and post-study visit * Laboratory test : screening, post-dose 24hour
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication
Ajou University Hospital
Suwon, South Korea
analysis of Alendronate concentrate
If the CrCL value is less than 75%, it is considered that collected urine is not appropriate and collected urine is exclusived for analysis of pharmacokinetics
Time frame: pre-dose, post dose 0-6hour, 6-12hour, 12-24hour
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