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HDDO-1614 Intervention Trial

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bazedoxifene 20 mg
Cholecalciferol
Bazedoxifene 20mg and Cholecalciferol
Sponsored by
Hyundai Pharmaceutical Co., LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoporosis

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Inha University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Bazedoxifene 20mg

Cholecalciferol

Bazedoxifene 20mg and Cholecalciferol

Arm Description

Subjects will take bazedoxifene 1 Tablet.

Subjects will take Cholecalciferol 2 Tablets.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetic Assessment
Bazedoxifene Maximum Plasma Concentration
Pharmacokinetic Assessment
Bazedoxifene Area Under Curve
Pharmacokinetic Assessment
Maximun Plasma Concentration after correction of basal concentration of Cholecalciferol
Pharmacokinetic Assessment
Area Under Curve after correction of basal concentration of Cholecalciferol

Full Information

First Posted
July 26, 2017
Last Updated
December 8, 2017
Sponsor
Hyundai Pharmaceutical Co., LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT03234244
Brief Title
HDDO-1614 Intervention Trial
Official Title
A Randomized, Open-label, Single-dose Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of HDDO-16141 and HDDO-16142 in Healthy Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
August 14, 2017 (Actual)
Study Completion Date
August 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hyundai Pharmaceutical Co., LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bazedoxifene 20mg
Arm Type
Active Comparator
Arm Description
Subjects will take bazedoxifene 1 Tablet.
Arm Title
Cholecalciferol
Arm Type
Active Comparator
Arm Description
Subjects will take Cholecalciferol 2 Tablets.
Arm Title
Bazedoxifene 20mg and Cholecalciferol
Arm Type
Experimental
Arm Description
Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
Intervention Type
Drug
Intervention Name(s)
Bazedoxifene 20 mg
Intervention Description
To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Description
To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.
Intervention Type
Drug
Intervention Name(s)
Bazedoxifene 20mg and Cholecalciferol
Intervention Description
For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
Primary Outcome Measure Information:
Title
Drug-Drug Interaction
Description
To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.
Time Frame
Day 1~Day 56
Secondary Outcome Measure Information:
Title
Pharmacokinetic Assessment
Description
Bazedoxifene Maximum Plasma Concentration
Time Frame
0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
Title
Pharmacokinetic Assessment
Description
Bazedoxifene Area Under Curve
Time Frame
0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
Title
Pharmacokinetic Assessment
Description
Maximun Plasma Concentration after correction of basal concentration of Cholecalciferol
Time Frame
Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
Title
Pharmacokinetic Assessment
Description
Area Under Curve after correction of basal concentration of Cholecalciferol
Time Frame
Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Heon Cho
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inha University Hospital
City
Junggu
State/Province
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of

12. IPD Sharing Statement

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HDDO-1614 Intervention Trial

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