Osteoporosis | Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women
Osteoporosis research study
What is the primary objective of this study?
This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Maxmarvil®Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2011
Completed Date: September 2012
Phase: Phase 1
Primary Outcome: analysis of Alendronate concentrate
Study sponsors, principal investigator, and references
Principal Investigator: yoon-suk chung, MD,PhD
Lead Sponsor: Yuyu Pharma, Inc.