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CompletedNCT04755894Updated Feb 17, 2021

HDDO-1756 Bio Equivalence Study

A Phase 1 interventional study of HDDO-1756 and HDDO-17561/HDDO-17562 in Hyperlipidemias, sponsored by Hyundai Pharmaceutical Co., LTD.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Hyundai Pharmaceutical Co., LTD. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jun 2020, registered Feb 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
19 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Hyperlipidemias

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03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 56 is below the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Hyundai Pharmaceutical Co., LTD. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy adult volunteers aged 19 or older during screening
  2. 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

  3. A person who has no chronic disease or medical treatment and has no pathological symptoms or findings as a result of an internal examination;
  4. 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

Exclusion Criteria:

  1. 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:
  2. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  3. 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;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    group A

    Drug: HDDO-1756

  • Active comparator
    group B

    Drug: HDDO-17561/HDDO-17562

Interventions

  • DrugHDDO-1756

    single dose

  • DrugHDDO-17561/HDDO-17562

    single dose

06

What researchers measure

Primary outcomes

  1. pharmacokinetic evaluation variables

    Cmax

    Time frame: 0~96 hours

  2. pharmacokinetic evaluation variables

    AUC

    Time frame: 0~96 hours

07

Study locations

1 site
  • Hyundai Pharm
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04755894
Lead sponsor
Hyundai Pharmaceutical Co., LTD.
Responsible party
Sponsor
First posted
Feb 16, 2021
Start date
Jun 12, 2020
Primary completion
Jun 19, 2020
Completion
Jul 27, 2020
Last update
Feb 17, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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