Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women (YY_PK_2011)

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Maxmarvil®

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Maxmarvil®; single-arm study	Drug: Maxmarvil®; Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication; Other Names: Alendronate 5mg + calcitriol 0.5 μg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pre-dose, post dose 0-6hour, 6-12hour, 12-24hour

Collaborators and Investigators

• Sponsor: Yuyu Pharma, Inc.
• Investigators: Principal Investigator: yoon-suk chung, MD,PhD, Ajou university hospotal

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: February 1, 2012
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: alendronate; Maxmarvil®
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Alendronate; Calcitriol; Maxmarvil
• Other Study ID Numbers: YY_PK_2011