Back to resultsHDDO-1614 Bio Equivalence Study
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HDDO-1614
Bazedoxifene / Cholecalciferol
Sponsored by
About this trial
This is an interventional other trial for Osteoporosis
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, and 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 ≤ 100mm Hg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
- Those who have a history of drug or who have a positive urine drug test
Sites / Locations
- Inha University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HDDO-1614
Bazedoxifene + Cholecalciferol
Arm Description
Bazedoxifene + Cholecalciferol combination drug
Co-administration of Bazedoxifene and Cholecalciferol
Outcomes
Primary Outcome Measures
Bio-Equivalence between test drug and comparators
To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614
Secondary Outcome Measures
Bazedoxifene Pharmacokinetic Assessment
Bazedoxifene Maximum Plasma Concentration
Cholecalciferol Pharmacokinetic Assessment
Maximum Plasma Concentration after correction of basal concentration of Cholecalciferol
Full Information
NCT ID
NCT03382314
First Posted
December 7, 2017
Last Updated
February 23, 2018
Sponsor
Hyundai Pharmaceutical Co., LTD.
1. Study Identification
Unique Protocol Identification Number
NCT03382314
Brief Title
HDDO-1614 Bio Equivalence Study
Official Title
A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics After Co-administration of HDDO-16141 and HDDO-16143 and Administration of HDDO-1614 in Healthy Adult Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
December 21, 2017 (Actual)
Study Completion Date
January 5, 2018 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized, open-label, single-dose, crossover study
Detailed Description
This clinical trial is conducted with a randomized, open-label, single-dose, and cross over study designs. Investigators will compare the pharmacokinetic parameters of test drug(single oral dose, single administration) with pharmacokinetic parameters of comparator 1 and 2(combined administration, single oral dose).
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
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HDDO-1614
Arm Type
Experimental
Arm Description
Bazedoxifene + Cholecalciferol combination drug
Arm Title
Bazedoxifene + Cholecalciferol
Arm Type
Active Comparator
Arm Description
Co-administration of Bazedoxifene and Cholecalciferol
Intervention Type
Combination Product
Intervention Name(s)
HDDO-1614
Intervention Description
Combination drug (Bazedoxifene + Cholecalciferol)
Incrementally modified drug
Not market authorized product
Intervention Type
Drug
Intervention Name(s)
Bazedoxifene / Cholecalciferol
Intervention Description
Co- Administration of Bazedoxifene and Cholecalciferol
Primary Outcome Measure Information:
Title
Bio-Equivalence between test drug and comparators
Description
To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614
Time Frame
Day 1 ~ Day 27
Secondary Outcome Measure Information:
Title
Bazedoxifene 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
Cholecalciferol Pharmacokinetic Assessment
Description
Maximum 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
10. Eligibility
Sex
Male
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, and 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 ≤ 100mm Hg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
Those who have a history of drug or who have a positive urine drug test
Facility Information:
Facility Name
Inha University Hospital
City
Junggu
State/Province
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
HDDO-1614 Bio Equivalence Study
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