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

NCT03444402 | Completed Phase 1

• 1 other identifier: 173HPS17013
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

GERD

Keywords

CKD-381; Nexium

Outcome Measures

Primary Outcomes (1)

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

  Evaluation PK esomeprazole after multiple dose

  0~24h

Secondary Outcomes (12)

• Cmax,ss(Maximum concentration of drug in plasma at steady state)

  0~24h

• Tmax,ss(Time to maximum plasma concentration at steady state)

  0~24h

• t1/2(Terminal elimination half-life)

  0~24h

• R(Accumulation ratio)

  0~24h

• CLss/F(Apparent Clearance at steady state)

  0~24h

Study Arms (3)

Group A

EXPERIMENTAL

Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)

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

Group B

EXPERIMENTAL

Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)

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

Group C

EXPERIMENTAL

Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)

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

Interventions

CKD-381(formulation I) DRUG

1 tablet administered before the breakfast during 7 days

Group A; Group B; Group C

CKD-381(formulation II) DRUG

1 tablet administered before the breakfast during 7 days

Group A; Group B; Group C

D026(Nexium 40mg) DRUG

1 tablet administered before the breakfast during 7 days

Group A; Group B; Group C

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Kyung Sang Yu, M.D

  Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 23, 2018
• Study Start: March 2, 2018
• Primary Completion: May 4, 2018
• Study Completion: May 4, 2018
• Last Updated: May 24, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)