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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: GERD

Treatments: Drug: CKD-381

Study type: Interventional

Funder types: Industry

Identifiers

NCT04830930

A73_04FDI2102

Details and patient eligibility

About

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

Full 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

Enrollment: 28 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Sequence 1

Experimental group

Description:

Period 1: fasted condition/ Period 2: fed condition

Treatment:

Drug: CKD-381

Sequence 2

Experimental group

Description:

Period 1: fed condition/ Period 2: fasted condition

Treatment:

Drug: CKD-381