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OpenTrials
Completed

NCT Number: NCT03558425

A Study to Compare PK, PD and Safety of CKD-381 and D026 in Healthy Subjects

A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy subjects

Completed

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul Nat'l University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 19 aged and 50 aged in healthy male adult
  • Body weight more than 55kg
  • Body Mass Index more than 18.5 and under 25

Exclusion criteria

  • Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
  • Have a gastrointestinal disease history that can effect drug absorption or surgery.
  • Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product, additives or benzimidazole family.

Treatment and study plan

CKD-381

Drug

1 tablet administered before the breakfast during 7 days

D026

Drug

1 tablet administered before the breakfast during 7 days

Primary outcomes

  1. AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)

    Time frame: 0~24h

    Evaluation PK for Esomeprazole after multiple dose

  2. Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose

    Time frame: Baseline versus Multiple dose during 7 days

    Evaluation PD for ambulatory 24hr pH monitor

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D026 in Healthy Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2018
Registry last updated
Oct 12, 2018

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.

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