Back to resultsHDDO-1756 Bio Equivalence Study
Primary Purpose
Hyperlipidemias
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HDDO-1756
HDDO-17561/HDDO-17562
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemias
Eligibility Criteria
Inclusion Criteria:
- Healthy adult volunteers aged 19 or older during screening
A person who weighs more than 50.0 kg and has a BMI of 18.0 kg/m2 or less and 30.0 kg/m2 or less.
☞ BMI (kg/m2) = Weight (kg) / {Long (m)}2
- A person who has no chronic disease or medical treatment and has no pathological symptoms or findings as a result of an internal examination;
- A person who has been determined to be eligible for a clinical trial according to the characteristics of the drug during screening, such as serum tests, hematologic tests, hematological tests, urine tests, urine tests, etc. and vital signs (physical tests) and 12-lead ECG tests.
Exclusion Criteria:
- Current or past history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, urinary system, cardiovascular system, digestive system, musculoskeletal disease, or mental illness, as well as those with the following symptoms or history:
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Persons with a history of gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of drugs;
Sites / Locations
- Hyundai Pharm
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group A
group B
Arm Description
Outcomes
Primary Outcome Measures
pharmacokinetic evaluation variables
Cmax
pharmacokinetic evaluation variables
AUC
Secondary Outcome Measures
Full Information
NCT ID
NCT04755894
First Posted
February 8, 2021
Last Updated
February 15, 2021
Sponsor
Hyundai Pharmaceutical Co., LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04755894
Brief Title
HDDO-1756 Bio Equivalence Study
Official Title
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of HDDO-1756 or Loose Combination of HDDO-17561/HDDO-17562 in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
June 19, 2020 (Actual)
Study Completion Date
July 27, 2020 (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
For healthy adult volunteers, safety and pharmacokinetic properties are compared between the two formulations in the case of HDDO-1756 alone administration and HDDO-17561/HDDO-17562 combined administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Title
group B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
HDDO-1756
Intervention Description
single dose
Intervention Type
Drug
Intervention Name(s)
HDDO-17561/HDDO-17562
Intervention Description
single dose
Primary Outcome Measure Information:
Title
pharmacokinetic evaluation variables
Description
Cmax
Time Frame
0~96 hours
Title
pharmacokinetic evaluation variables
Description
AUC
Time Frame
0~96 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult volunteers aged 19 or older during screening
A person who weighs more than 50.0 kg and has a BMI of 18.0 kg/m2 or less and 30.0 kg/m2 or less.
☞ BMI (kg/m2) = Weight (kg) / {Long (m)}2
A person who has no chronic disease or medical treatment and has no pathological symptoms or findings as a result of an internal examination;
A person who has been determined to be eligible for a clinical trial according to the characteristics of the drug during screening, such as serum tests, hematologic tests, hematological tests, urine tests, urine tests, etc. and vital signs (physical tests) and 12-lead ECG tests.
Exclusion Criteria:
Current or past history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, urinary system, cardiovascular system, digestive system, musculoskeletal disease, or mental illness, as well as those with the following symptoms or history:
Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Persons with a history of gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of drugs;
Facility Information:
Facility Name
Hyundai Pharm
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
HDDO-1756 Bio Equivalence Study
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