HyperlipidemiasPhase 1NCT04755894
HDDO-1756 Bio Equivalence Study
A Phase 1 study testing HDDO-1756 and HDDO-17561/HDDO-17562 in people with Hyperlipidemias, run by Hyundai Pharmaceutical Co., LTD. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- HDDO-1756 and HDDO-17561/HDDO-17562
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jun 2020to 27 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Conditions
- Hyperlipidemias
- Being tested
- HDDO-1756, HDDO-17561/HDDO-17562
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDDO-1756Drug
single dose
HDDO-17561/HDDO-17562Drug
single dose
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Not described Receives: Drug: HDDO-1756 |
| group B | Active comparator | Not described Receives: Drug: HDDO-17561/HDDO-17562 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic evaluation variables
Cmax
Measured: 0~96 hours
pharmacokinetic evaluation variables
AUC
Measured: 0~96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start12 Jun 2020
- Primary completion19 Jun 2020
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755894
- Sponsor's protocol ID
- HT-013-01
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04755894
- Acronym / sponsor ID
- HT-013-01
- Conditions
- Hyperlipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 19 Jun 2020 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: HDDO-1756 |
| group B | Active comparator | Drug: HDDO-17561/HDDO-17562 |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDDO-1756single dose | Drug | group A |
| HDDO-17561/HDDO-17562single dose | Drug | group B |
Primary outcome
pharmacokinetic evaluation variables
Time frame: 0~96 hours
Cmax
pharmacokinetic evaluation variables
Time frame: 0~96 hours
AUC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HDDO-1756 and HDDO-17561/HDDO-17562 in people with Hyperlipidemias, run by Hyundai Pharmaceutical Co., LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetic evaluation variables (time frame: 0~96 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.