HDDO-1614 Intervention Trial

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

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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