Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg

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

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000701

Enrollment

Registered

2013-03-15

Start date

2012-11-01

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : experimental: HCP1004 active comparator: vimovo single dose, cross over

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. BMI: 18.0 - 27.0 kg/m2 2. Willingness to sign the written Informed Consent Form

Exclusion criteria

Exclusion criteria: 1.Evidence of clinically relevant pathology 2.History of relevant drug and food allergies 3.Positive screen on drugs of abuse 4.Participation in a drug study within 3months prior to drug administration.

Design outcomes

Primary

Measure	Time frame
AUClast Naproxen and Esomeprazole ;Cmax of Naproxen and Esomeprazole	—

Secondary

Measure	Time frame
Tmax, t1/2, CL/F, AUCinf of Naproxen and Esomeprazole ;t1/2 of Naproxen and Esomeprazole ;CL/F of Naproxen and Esomeprazole ; AUCinf of Naproxen and Esomeprazole	—

Countries

Korea, Republic of

Contacts

Public ContactHyeKyung Han

Seoul National University Hospital

Outcome results