HDDO-1756 Bio Equivalence Study

NCT04755894 | Completed Phase 1

• 1 other identifier: HT-013-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (2)

• pharmacokinetic evaluation variables

  Cmax

  0~96 hours

• pharmacokinetic evaluation variables

  AUC

  0~96 hours

Study Arms (2)

group A

EXPERIMENTAL

Drug: HDDO-1756

group B

ACTIVE COMPARATOR

Drug: HDDO-17561/HDDO-17562

Interventions

HDDO-1756 DRUG

single dose

group A

HDDO-17561/HDDO-17562 DRUG

single dose

group B

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hyundai Pharmaceutical Co., LTD.: lead

Study Sites (1)

Hyundai Pharm

Seoul, South Korea

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 16, 2021
• Study Start: June 12, 2020
• Primary Completion: June 19, 2020
• Study Completion: July 27, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

KR (1)