HDDO-1756 Bio Equivalence Study

Hyperlipidemias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04755894
• Other study ID #: HT-013-01
• Status: Completed
• Phase: Phase 1
• Start date: June 12, 2020
• Est. completion date: July 27, 2020

Study information

• Verified date: February 2021
• Source: Hyundai Pharmaceutical Co., LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 27, 2020
• Est. primary completion date: June 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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:

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;

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Drug:
• HDDO-1756
single dose
• HDDO-17561/HDDO-17562
single dose

Locations

Country	Name	City	State
Korea, Republic of	Hyundai Pharm	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hyundai Pharmaceutical Co., LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetic evaluation variables	Cmax	0~96 hours
Primary	pharmacokinetic evaluation variables	AUC	0~96 hours