HDDO-1756 Bio Equivalence Study

Phase 1

Completed

• Conditions: Hyperlipidemias
• Interventions: Drug: HDDO-17561/HDDO-17562; Drug: HDDO-1756

• Registration Number: NCT04755894
• Lead Sponsor: Hyundai Pharmaceutical Co., LTD.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-12
• Primary Completion: 2020-06-19
• Study Completion: 2020-07-27
• Status Verified: 2021-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-14
• Last Update Submitted: 2021-02-15
• Study First Posted: 2021-02-16
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group B	HDDO-17561/HDDO-17562	-
group A	HDDO-1756	-

Primary Outcome Measures

Name	Time	Method
pharmacokinetic evaluation variables	0~96 hours	AUC

Trial Locations

Locations (1)

Hyundai Pharm; 🇰🇷 Seoul, Korea, Republic of