Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women

NCT ID: NCT01526278

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-09-30

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

Conditions

Osteoporosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Maxmarvil®

single-arm study

Group Type: OTHER

Maxmarvil®

Intervention Type: DRUG

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

Interventions

Maxmarvil®

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

Intervention Type: DRUG

Other Intervention Names

Alendronate 5mg + calcitriol 0.5 μg

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuyu Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yoon-suk chung, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Ajou university hospotal

Locations

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

Other Identifiers

YY_PK_2011

Identifier Type: -

Identifier Source: org_study_id