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Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women (YY_PK_2011)

This study is currently recruiting participants.
Verified February 2012 by Yuyu Pharma, Inc.
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
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoporosis
 Drug: Maxmarvil®
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of a Single Oral Dose of Maxmarvil® in Healthy Postmenopausal Women Without a Previous History of Fractures

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by Yuyu Pharma, Inc.:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Maxmarvil®
single-arm study
 Drug: Maxmarvil®
Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication
Other Name: Alendronate 5mg + calcitriol 0.5 μg

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 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
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526278

Contacts
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

Locations
Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Contact: Yoon-suk Chung, MD,PhD     82-31-219-5127     yschung@ajou.ac.kr    
Contact: Min-suk Lee, MD     82-31-5162-2751     nomore1@gmail.com    
Sponsors and Collaborators
Yuyu Pharma, Inc.
Investigators
Principal Investigator: yoon-suk chung, MD,PhD Ajou university hospotal
  More Information

No publications provided

Responsible Party: Yuyu Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01526278     History of Changes
Other Study ID Numbers: YY_PK_2011
Study First Received: February 1, 2012
Last Updated: February 13, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yuyu Pharma, Inc.:
alendronate
Maxmarvil®

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013