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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
  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:


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
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

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
Bone Diseases, Metabolic
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014