HDDO-1614 Intervention Trial

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Bazedoxifene 20 mg; Drug: Bazedoxifene 20mg and Cholecalciferol; Drug: Cholecalciferol

• Registration Number: NCT03234244
• Lead Sponsor: Hyundai Pharmaceutical Co., LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study Start: 2017-04-12
• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-31
• Primary Completion: 2017-08-14
• Study Completion: 2017-08-14
• Last Update Submitted: 2017-12-08
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bazedoxifene 20mg	Bazedoxifene 20 mg	Subjects will take bazedoxifene 1 Tablet.
Bazedoxifene 20mg and Cholecalciferol	Bazedoxifene 20mg and Cholecalciferol	Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
Cholecalciferol	Cholecalciferol	Subjects will take Cholecalciferol 2 Tablets.

Primary Outcome Measures

Name	Time	Method
Drug-Drug Interaction	Day 1~Day 56	To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.

Secondary Outcome Measures

Name	Time	Method
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	Area Under Curve after correction of basal concentration of Cholecalciferol

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Junggu, Incheon, Korea, Republic of