None listed
Conditions
Interventions
Drug : Reference drug: Arava, Sanofi-Aventis Deutschland GmbH
Test drug: CJ leflunomide 10mg
Single dose, oral dose
Sponsors
CJ CheilJedang
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible volunteers were aged 19-55 years and weighed within ±20% of the standard weight according to Broca’s formula. All volunteers were healthy as confirmed by medical history, physical examination, vital signs measurements, 12-lead electrocardiography, chest X-ray examination, and laboratory tests, including biochemistry, hematology, immune serum, and urinalysis. Women who were pregnant were excluded, and women of child-bearing age had to have used medically acceptable birth control for 3 months before the study and had to continue for 3 months after the study. All tests were performed at the Clinical Trial Center, Inje University Busan Paik Hospital.
Exclusion criteria
Exclusion criteria: The exclusion criteria were as follows: medical history of lung disease such as interstitial pneumonitis, pulmonary fibrosis, and pneumonitis due to an opportunistic infection; medical history of drug allergy or clinically relevant allergic diseases; taking any medicine that could affect the induction or inhibition of drug metabolizing enzymes within 30 days before the start of the trial; using any medication within 10 days before the start of the trial that could affect the study results; blood donation in the 60-day period prior to dosing; participation in other clinical trials within 90 days; smoking or alcohol consumption >14 units/week; abnormal clinical laboratory test results or other abnormal medical findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters(AUCt, Cmax) | — |
Countries
Korea, Republic of
Contacts
Public ContactKim Eun Young
Inje University Busan Paik Hospital
Outcome results
None listed