A Study to Investigate the Effect of Food on the PK, PD of CKD-381 in Healthy Volunteers

Phase 1

Completed

• Conditions: GERD
• Interventions: Drug: CKD-381

• Registration Number: NCT04830930
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers

Detailed Description

A randomized, open-label, single-dose, crossover study to investigate the effect of food on the pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Study Start: 2021-04-21
• Primary Completion: 2021-06-17
• Study Completion: 2021-07-26
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Between 19 aged and 50 aged in healthy adult
2. Body weight more than 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2
3. Have negative result on Helicobacter Pylori antibody test

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Exclusion Criteria

1. 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.
2. Have a gastrointestinal disease history(including surgery) that can effect evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product.
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	CKD-381	Period 1: fasted condition/ Period 2: fed condition
Sequence 2	CKD-381	Period 1: fed condition/ Period 2: fasted condition

Primary Outcome Measures

Name	Time	Method
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose	0-24 hours
Cmax	0-24 hours	maximum observed concentration after dose
AUClast	0-24 hours	Area under the plasma concentration versus time curve over the dosing interval after dose

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of