Status:
COMPLETED
Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women
Lead Sponsor:
Yuyu Pharma, Inc.
Conditions:
Osteoporosis
Eligibility:
FEMALE
55+ years
Phase:
PHASE1
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 1h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01526278
Start Date
October 1 2011
End Date
September 1 2012
Last Update
February 25 2019
Active Locations (1)
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1
Ajou University Hospital
Suwon, South Korea