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
Sponsor:
Information provided by (Responsible Party):
Yuyu Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01526278
First received: February 1, 2012
Last updated: February 13, 2012
Last verified: February 2012

February 1, 2012
February 13, 2012
October 2011
July 2012   (final data collection date for primary outcome measure)
analysis of Alendronate concentrate [ Time Frame: pre-dose, post dose 0-6hour, 6-12hour, 12-24hour ] [ Designated as safety issue: Yes ]
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
Not Provided
Complete list of historical versions of study NCT01526278 on ClinicalTrials.gov Archive Site
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Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women
Pharmacokinetics of a Single Oral Dose of Maxmarvil® in Healthy Postmenopausal Women Without a Previous History of Fractures

This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women

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
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis
Drug: Maxmarvil®
Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication
Other Name: Alendronate 5mg + calcitriol 0.5 μg
No Intervention: Maxmarvil®
single-arm study
Intervention: Drug: Maxmarvil®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
September 2012
July 2012   (final data collection date for primary outcome measure)

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
Female
55 Years and older
Yes
Contact: yoon-suk chung, MD,Ph.D 82-31-219-5127 yschung@ajou.ac.kr
Contact: kyeongsuk seo, BS 82-2-2253-6600 ksseo@yuyu.co.kr
Korea, Republic of
 
NCT01526278
YY_PK_2011
Yes
Yuyu Pharma, Inc.
Yuyu Pharma, Inc.
Not Provided
Principal Investigator: yoon-suk chung, MD,PhD Ajou university hospotal
Yuyu Pharma, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP