Back to resultsPharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women (YY_PK_2011)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Maxmarvil®
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring alendronate, Maxmarvil®
Eligibility 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
Sites / Locations
- Ajou University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Maxmarvil®
Arm Description
single-arm study
Outcomes
Primary Outcome Measures
analysis of Alendronate concentrate
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01526278
Brief Title
Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women
Acronym
YY_PK_2011
Official Title
Pharmacokinetics of a Single Oral Dose of Maxmarvil® in Healthy Postmenopausal Women Without a Previous History of Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuyu Pharma, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
alendronate, Maxmarvil®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maxmarvil®
Arm Type
Other
Arm Description
single-arm study
Intervention Type
Drug
Intervention Name(s)
Maxmarvil®
Other Intervention Name(s)
Alendronate 5mg + calcitriol 0.5 μg
Intervention Description
Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication
Primary Outcome Measure Information:
Title
analysis of Alendronate concentrate
Description
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
Time Frame
pre-dose, post dose 0-6hour, 6-12hour, 12-24hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yoon-suk chung, MD,PhD
Organizational Affiliation
Ajou university hospotal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women
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