NCT03234244

Brief Summary

Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2017

Completed
Last Updated

December 11, 2017

Status Verified

April 1, 2017

Enrollment Period

4 months

First QC Date

July 26, 2017

Last Update Submit

December 8, 2017

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Drug-Drug Interaction

    To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.

    Day 1~Day 56

Secondary Outcomes (4)

  • Pharmacokinetic Assessment

    0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours

  • Pharmacokinetic Assessment

    0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours

  • Pharmacokinetic Assessment

    Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour

  • Pharmacokinetic Assessment

    Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour

Study Arms (3)

Bazedoxifene 20mg

ACTIVE COMPARATOR

Subjects will take bazedoxifene 1 Tablet.

Drug: Bazedoxifene 20 mg

Cholecalciferol

ACTIVE COMPARATOR

Subjects will take Cholecalciferol 2 Tablets.

Drug: Cholecalciferol

Bazedoxifene 20mg and Cholecalciferol

EXPERIMENTAL

Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.

Drug: Bazedoxifene 20mg and Cholecalciferol

Interventions

Bazedoxifene 20 mgDRUG

To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.

Bazedoxifene 20mg
CholecalciferolDRUG

To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.

Cholecalciferol
Bazedoxifene 20mg and CholecalciferolDRUG

For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.

Bazedoxifene 20mg and Cholecalciferol

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body weight 50kg ≤ / BMI=18\~29kg/㎡
  • 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

You may not qualify if:

  • Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular
  • 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
  • AST or ALT \> 2 times upper limit of normal range
  • Total Bilirubin \> 2.0mg/dL
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha University Hospital

Junggu, Incheon, 22332, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

bazedoxifeneCholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Sang-Heon Cho

    Inha University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 31, 2017

Study Start

April 12, 2017

Primary Completion

August 14, 2017

Study Completion

August 14, 2017

Last Updated

December 11, 2017

Record last verified: 2017-04

Locations

KR(1)