Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women

Study Overview
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Brief Summary
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This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women

Detailed Description
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Pharmacokinetics of a single Oral Dose of Maxmarvil® in healthy postmenopausal women without a previous history of fractures evaluation of Pharmacokinetics Urine collection : Pre-dose(pre 1hour), post-dose 0 6 hour, 6 12 hour, 12 24 hour Evaluation Variables : Aet 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

Official Title
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Pharmacokinetics of a Single Oral Dose of Maxmarvil® in Healthy Postmenopausal Women Without a Previous History of Fractures

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Maxmarvil®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Maxmarvil®<br>single-arm study | Drug: Maxmarvil®<br>* Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication<br>* Other names: Alendronate 5mg + calcitriol 0.5 μg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | pre-dose, post dose 0-6hour, 6-12hour, 12-24hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alendronate, Maxmarvil®