HDDO-1756 Bio Equivalence Study

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 19, 2020

Interventions

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

Arms, Groups and Cohorts

  • Experimental: group A
  • Active Comparator: group B

Clinical Trial Outcome Measures

Primary Measures

  • pharmacokinetic evaluation variables
    • Time Frame: 0~96 hours
    • Cmax
  • pharmacokinetic evaluation variables
    • Time Frame: 0~96 hours
    • AUC

Participating in This Clinical Trial

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;

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hyundai Pharmaceutical Co., LTD.
  • Provider of Information About this Clinical Study
    • Sponsor

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