OsteoporosisPhase 1YY_PK_2011NCT01526278
Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women
A Phase 1 study testing Maxmarvil® in people with Osteoporosis, run by Yuyu Pharma, Inc. at 1 site in South Korea.
Trial summary
This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Maxmarvil®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Osteoporosis
- Being tested
- Maxmarvil®
- Keywords
- alendronate, Maxmarvil®
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxmarvil®Drug
Also called Alendronate 5mg + calcitriol 0.5 μg
Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication
| Study group | Role | What they receive |
|---|---|---|
| Maxmarvil® | Other | single-arm study Receives: Drug: Maxmarvil® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre-dose, post dose 0-6hour, 6-12hour, 12-24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuyu Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yoon-suk chung, MD,PhD, Principal investigator, Ajou university hospotal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526278
- Sponsor's protocol ID
- YY_PK_2011
- Acronym
- YY_PK_2011
- Status last verified
- Feb 2019
- First submitted
- 1 Feb 2012
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of a Single Oral Dose of Maxmarvil® in Healthy Postmenopausal Women Without a Previous History of Fractures
- ClinicalTrials.gov ID
- NCT01526278
- Acronym / sponsor ID
- YY_PK_2011 / YY_PK_2011
- Conditions
- Osteoporosis
- Keywords
- alendronate, Maxmarvil®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Yuyu Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maxmarvil® | Other | Drug: Maxmarvil®single-arm study |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxmarvil®Also: Alendronate 5mg + calcitriol 0.5 μgDrug : Maxmarvil® 1tablet one time in clinical trial, PO medication | Drug | Maxmarvil® |
Primary outcome
analysis of Alendronate concentrate
Time frame: pre-dose, post dose 0-6hour, 6-12hour, 12-24hour
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yoon-suk chung, MD,PhD principal investigator
Ajou university hospotal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Maxmarvil® in people with Osteoporosis, run by Yuyu Pharma, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analysis of Alendronate concentrate (time frame: pre-dose, post dose 0-6hour, 6-12hour, 12-24hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.