pharmacokinetics of maxmarvil® in healthy postmenopausal women

Conditions: Osteoporosis

Summary: 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

Eligibility criteria:
inclusion criteria: * screening test in healthy postmenopausal women without a previous history of fracture * normal range in laboratory test arranged by principal investigator because of the character of medicine * over 50kg, body weight is in ± 20% of ideal body weight written concent by himself and following the protocol after understanding of the explained clinical trial exclusion criteria: * subject who have taken something to induce and inhibit the drug metabolizing enzyme within 1 month like barbiturate. * subject who have a history of drug abuse and got a positive in urine test for drug abuse. * subject who have taken a prescription only medicine or an oriental medicine within 2 weeks after first administration the clinical drug trial , taken a otc within 1 week after first administration the clinical drug trial like some otc including calcium, an antacids, multiple vitamin, mineral. * subject who have been chronic drinking(over 21 units/week) or can not stop drinking during the clinical trial. * subject who have smoked over 10 unit/day for 3months. * subject who have light or clear hypersensitivity reaction about otc(aspirin, antibiotic medication) or bisphosphonates(alendronate) * subject who have got a disease about liver, kidney, neurology, respiratory, endocrine, hematooncology, cardiovascular, musculoskeletal, psychological or history of fracture within 12months or a tooth extraction within 6month * subject who have a history of gastrointestinal disease or stomach surgery without appendectomy, herniotomy having an effort the absorb of clinical drug trial. * subject who have a esophageal disease like esophagitis, esophageal ulcer, esophagus erosion, esophagorrhaphy, esophagostenosis, dysphagia. * subject who can not keep the sitting position for 30minutes * subject who is out of normal range of calcium concentration in blood (8.8 \~ 10.5 mg/dl) * subject who is hypotension(systolic blood pressure ≤ 90mmhg or diastolic blood pressure ≤ 50 mmhg ) or hypertension(systolic blood pressure ≥ 150mmhg or diastolic blood pressure ≥ 100 mmhg ) in sitting position after rest 3 minutes * join the other clinical trial within 2months after administration of the clinical drug trial. * subject who have donated whole blood within 2 months or plasma within 1 month. * subject who have a grapefruit and something including caffeine in close season(from 3 days before administration to discharge from the hospital ) * for the result of laboratory and the other reason subject is considered unsuitable by principal's decision

Keywords: alendronate maxmarvil®