HDDO-1614 Bio Equivalence Study
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
1 other identifier
interventional
38
1 country
1
Brief Summary
A randomized, open-label, single-dose, crossover study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2017
CompletedFirst Submitted
Initial submission to the registry
December 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2017
CompletedFirst Posted
Study publicly available on registry
December 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2018
CompletedFebruary 26, 2018
February 1, 2018
2 months
December 7, 2017
February 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Bio-Equivalence between test drug and comparators
To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614
Day 1 ~ Day 27
Secondary Outcomes (2)
Bazedoxifene Pharmacokinetic Assessment
0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
Cholecalciferol 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
Study Arms (2)
HDDO-1614
EXPERIMENTALBazedoxifene + Cholecalciferol combination drug
Bazedoxifene + Cholecalciferol
ACTIVE COMPARATORCo-administration of Bazedoxifene and Cholecalciferol
Interventions
* Combination drug (Bazedoxifene + Cholecalciferol) * Incrementally modified drug * Not market authorized product
Co- Administration of Bazedoxifene and Cholecalciferol
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inha University Hospital
Junggu, Incheon, 22332, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2017
First Posted
December 22, 2017
Study Start
October 16, 2017
Primary Completion
December 21, 2017
Study Completion
January 5, 2018
Last Updated
February 26, 2018
Record last verified: 2018-02