Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women

NCT01526278 | Completed Phase 1 DMC

• 1 other identifier: YY_PK_2011
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women

Conditions

Osteoporosis

Keywords

alendronate; Maxmarvil®

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Maxmarvil®

OTHER

single-arm study

Drug: Maxmarvil®

Interventions

Maxmarvil® DRUG

Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication

Also known as: Alendronate 5mg + calcitriol 0.5 μg

Maxmarvil®

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Yuyu Pharma, Inc.: lead

Study Sites (1)

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Maxmarvil; Alendronate; Calcitriol

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• yoon-suk chung, MD,PhD

  Ajou university hospotal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 3, 2012
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

KR (1)