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

C

Chong Kun Dang

Status and phase

Completed
Phase 1

Conditions

GERD

Treatments

Drug: CKD-381(formulation II)
Drug: CKD-381(formulation I)
Drug: D026(Nexium 40mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03444402
173HPS17013

Details and patient eligibility

About

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

Full description

A randomized, open-label, multiple-dose, and three-way cross over clinical trial to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

Enrollment

18 patients

Sex

Male

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

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 Esomeprazole, additives or benzimidazole family.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

18 participants in 3 patient groups

Group A
Experimental group
Description:
Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)
Treatment:
Drug: D026(Nexium 40mg)
Drug: CKD-381(formulation I)
Drug: CKD-381(formulation II)
Group B
Experimental group
Description:
Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)
Treatment:
Drug: D026(Nexium 40mg)
Drug: CKD-381(formulation I)
Drug: CKD-381(formulation II)
Group C
Experimental group
Description:
Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)
Treatment:
Drug: D026(Nexium 40mg)
Drug: CKD-381(formulation I)
Drug: CKD-381(formulation II)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems