Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women (YY_PK_2011)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Yuyu Pharma, Inc..
Recruitment status was Recruiting
Information provided by (Responsible Party):
Yuyu Pharma, Inc.
First received: February 1, 2012
Last updated: February 13, 2012
Last verified: February 2012
This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women
||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Pharmacokinetics of a Single Oral Dose of Maxmarvil® in Healthy Postmenopausal Women Without a Previous History of Fractures
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2012 (Final data collection date for primary outcome measure)
No Intervention: Maxmarvil®
Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication
Other Name: Alendronate 5mg + calcitriol 0.5 μg
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
|Ages Eligible for Study:
||55 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526278
|Ajou University Hospital
|Suwon, Korea, Republic of |
|Contact: Yoon-suk Chung, MD,PhD 82-31-219-5127 firstname.lastname@example.org |
|Contact: Min-suk Lee, MD 82-31-5162-2751 email@example.com |
Yuyu Pharma, Inc.
||yoon-suk chung, MD,PhD
||Ajou university hospotal
No publications provided
||Yuyu Pharma, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 1, 2012
||February 13, 2012
||Korea: Food and Drug Administration
Keywords provided by Yuyu Pharma, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 19, 2014
Bone Diseases, Metabolic
Bone Density Conservation Agents
Physiological Effects of Drugs