Bioavailability Study of Leflunomide Tablets Under Fed Conditions (NCT00653003) | Clinical Trial Compass
CompletedPhase 1
Bioavailability Study of Leflunomide Tablets Under Fed Conditions
62 participantsStarted 2003-12
Plain-language summary
To compare the single-dose Bioavailability of Kali and Aventis
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects will meet all of the following criteria within 30 days prior to first drug administration(except inclusion #8)
* Healthy, surgically sterile (hysterectomy, bilateral oophorectomy) or postmenopausal (for al least 1 year)female subjects, 18 to 65 years of age(inclusive)
* Indicate non-child bearing status by one of the following criteria:
Indication of successful hysterectomy. No spontaneous menses for al least 1 year, must have luteinizing hormone (LH) and follicle stimulating hormone(FSH) levels within postmenopausal range.
Indication of successful bilateral oophorectomy.
* Body weight within 20% of the appropriate weight for the subject's height and frame (as published in the 1983 Metropolitan Life Insurance Company Scale, Statistical Bureau)
* Negative for:
HIV Hepatitis B surface antigen and Hepatitis C antibody Urine tests for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
Serum HCG consistent with pregnancy.
* No significant disease or clinically significant findings in a physical examination.
* No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram(ECG)
* Subjects who have received leflunomide within 4 months must have an A77-1726(Metabolite) level below 0.01ug/ml and no subsequent administration of leflunomide since that test. Note: The 30 day screening limit does not apply to this inclusion criterion.
* Be informed of the nature of th…