Osteoporosis
Conditions
Keywords
alendronate, Maxmarvil®
Brief summary
This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women
Detailed description
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
Interventions
DRUGMaxmarvil®
Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication
Sponsors
Yuyu Pharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| analysis of Alendronate concentrate | pre-dose, post dose 0-6hour, 6-12hour, 12-24hour | 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 |
Countries
South Korea
Outcome results
None listed