Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Maxmarvil®

• Registration Number: NCT01526278
• Lead Sponsor: Yuyu Pharma, Inc.

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

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

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-03
• Primary Completion: 2012-07
• Study Completion: 2012-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maxmarvil®	Maxmarvil®	single-arm study

Primary Outcome Measures

Name	Time	Method
analysis of Alendronate concentrate	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

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of