Overview

Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
Female
Summary
This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Yuyu Pharma, Inc.
Treatments:
Alendronate
Calcitriol
Maxmarvil
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