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

Rheumatoid Arthritis Clinical Trial

Official title:

Randomized, Open, 2-way Cross Over, Single Dose Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688193
• Other study ID #: HM-ESNP-102
• Status: Completed
• Phase: N/A
• First received: September 14, 2012
• Last updated: January 4, 2013
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Korea, Republic of	Seoul University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Wang-Smith L, Fort J, Zhang Y, Sostek M. Pharmacokinetics and relative bioavailability of a fixed-dose combination of enteric-coated naproxen and non-enteric-coated esomeprazole magnesium. J Clin Pharmacol. 2012 May;52(5):670-80. doi: 10.1177/0091270011405500. Epub 2011 May 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No