Skip to main content
OpenTrials
Completed

NCT Number: NCT04755894

HDDO-1756 Bio Equivalence Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hyundai Pharm

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

HDDO-1756

Drug

single dose

HDDO-17561/HDDO-17562

Drug

single dose

Primary outcomes

  1. pharmacokinetic evaluation variables

    Time frame: 0~96 hours

    Cmax

  2. pharmacokinetic evaluation variables

    Time frame: 0~96 hours

    AUC

Sponsors and collaborators

Lead sponsor

Hyundai Pharmaceutical Co., LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 16, 2021
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.