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HDDO-1614 Intervention Trial

H

Hyundai Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Osteoporosis

Treatments

Drug: Cholecalciferol
Drug: Bazedoxifene 20mg and Cholecalciferol
Drug: Bazedoxifene 20 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03234244
HT-008-01

Details and patient eligibility

About

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

Enrollment

37 patients

Sex

All

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

    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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

37 participants in 3 patient groups

Bazedoxifene 20mg
Active Comparator group
Description:
Subjects will take bazedoxifene 1 Tablet.
Treatment:
Drug: Bazedoxifene 20 mg
Cholecalciferol
Active Comparator group
Description:
Subjects will take Cholecalciferol 2 Tablets.
Treatment:
Drug: Cholecalciferol
Bazedoxifene 20mg and Cholecalciferol
Experimental group
Description:
Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
Treatment:
Drug: Bazedoxifene 20mg and Cholecalciferol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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