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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01688193

Enrollment

Registered

2012-09-19

Start date

2012-10-31

Completion date

2012-12-31

Last updated

2013-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

South Korea

Outcome results