Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01688193
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Study Start: 2012-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-04
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 68

Inclusion Criteria

• BMI: 18.0 - 27.0 kg/m2
• Willingness to sign the written Informed Consent Form

Exclusion Criteria

• Evidence of clinically relevant pathology
• History of relevant drug and food allergies
• Positive screen on drugs of abuse
• Participation in a drug study within 60 days prior to drug administration.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUClast, Cmax of Naproxen and Esomeprazole	Naproxen : 0h,30min, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72h, Esomeprazole : 0h, 10min, 20min, 30min, 45min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12h

Secondary Outcome Measures

Name	Time	Method
Tmax, t1/2, CL/F, AUCinf of Naproxen and Esomeprazole	Naproxen : 0h, 30min, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72h Esomeprazole: 0h, 10min, 20min, 30min, 45min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12h

Trial Locations

Locations (1)

Seoul University Hospital; 🇰🇷 Seoul, Korea, Republic of