Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2017-04-12
2017-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Bazedoxifene 20mg
Subjects will take bazedoxifene 1 Tablet.
Bazedoxifene 20 mg
To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.
Cholecalciferol
Subjects will take Cholecalciferol 2 Tablets.
Cholecalciferol
To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.
Bazedoxifene 20mg and Cholecalciferol
Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
Bazedoxifene 20mg and Cholecalciferol
For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
Interventions
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Bazedoxifene 20 mg
To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.
Cholecalciferol
To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.
Bazedoxifene 20mg and Cholecalciferol
For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
Eligibility Criteria
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Inclusion Criteria
* A person who is determined to be eligible for the test through a physical examination or an interview
* Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, urine test, serology test
Exclusion Criteria
* Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials
* Any person who shows any of the following results in the screening test
1. AST or ALT \> 2 times upper limit of normal range
2. Total Bilirubin \> 2.0mg/dL
3. Glomerular filtration rate (eGFR) \< 60mL / min/ 1.7㎡
* Those who show signs of hypotension (systolic blood pressure ≤ 100mmHg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
* Those who have a history of drug abuse or who have a positive urine drug test
19 Years
45 Years
ALL
Yes
Sponsors
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Hyundai Pharmaceutical Co., LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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Sang-Heon Cho
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Locations
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Inha University Hospital
Junggu, Incheon, South Korea
Countries
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Other Identifiers
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HT-008-01
Identifier Type: -
Identifier Source: org_study_id