Bioequivalence study of aceclofenac tablet

Bioequivalence study of 'Eifen tablet' produced by Daewoo Pharmaceutical Co.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001425

Enrollment

Registered

2015-03-30

Start date

2005-02-28

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 : Twenty healthy volunteers were randomly divided into two groups, 10 persons each. One-hundred miligram of Airtal tab. (reference drug) or Eifen tab. (test drug) was orally administered, and blo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 19~55 years old volunteers when they were exmined. • volunteers without both any inherited or chronic diseases and any pathologic symptoms/signs in physical examination • healthy volunteers judged by resulting from hematology, blood chemistry and urinalysis • no pregnant woman

Exclusion criteria

Exclusion criteria: • A person who administered any drug enzyme inducers/inhibitors and heavy alcohol within a month before starting this study • A person who administered any medicine which may affect this study within 10 days before initiation • A person judged as an inappropriate volunteer by the physician in charge

Design outcomes

Primary

Measure	Time frame
Maximum concentration, Area under the plasma concentration-time curve	—

Secondary

Measure	Time frame
Dissolution test results	—

Countries

Korea, Republic of

Contacts

Public ContactWonku Kang

Chung-Ang University

Outcome results