NCT01526278

Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women

Pharmacokinetics of a Single Oral Dose of Maxmarvil® in Healthy Postmenopausal Women Without a Previous History of Fractures

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Yuyu Pharma, Inc. · Industry
• Sex: Female
• Age: 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Maxmarvil®	Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-07-01
• Completion: 2012-09-01
• First posted: 2012-02-03
• Last updated: 2019-02-25

Locations

1 site across 1 country: South Korea