Pharmacokinetics and Bioequivalence Studies of Teriflunomide in Healthy Iranian Volunteers
| Autor: | Elham Ghasemian, Maryam Dibaei, Mohammad-Reza Rouini |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Toluidines Pharmaceutical Science Administration Oral Hydroxybutyrates Context (language use) Pharmacology Bioequivalence Iran 030226 pharmacology & pharmacy High-performance liquid chromatography Peak concentration 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Pharmacokinetics Teriflunomide Nitriles Medicine Drugs Generic Humans Pharmacology (medical) Chromatography High Pressure Liquid Cross-Over Studies Plasma samples business.industry Middle Aged Crossover study chemistry Therapeutic Equivalency 030220 oncology & carcinogenesis Area Under Curve Crotonates business |
| Zdroj: | Clinical pharmacology in drug developmentReferences. 9(3) |
| ISSN: | 2160-7648 |
| Popis: | Multiple sclerosis, which is characterized by inflammation and neurodegeneration, is considered a chronic disease of the central nervous system. Given the lack of pharmacokinetic evaluation of teriflunomide in the Iranian context, the present 2-way crossover study aimed to assess the pharmacokinetic properties and bioequivalence of 2 teriflunomide formulations. To this end, 2 single-dose generic and branded teriflunomide formulations were orally administered to 14 healthy Iranian male volunteers. A washout period of 21 days was allowed between the treatments. The plasma samples containing teriflunomide were analyzed by a simple and sensitive high-performance liquid chromatography method using standard ultraviolet detection. In addition, the pharmacokinetic parameters were calculated for bioequivalence evaluation. The peak area ratio between the teriflunomide and the internal standard was the source of calibration curves, which were linear over the range of 20-40,000 ng/mL (R2 = 0.9994). The results indicated that the 2 formulations had similar pharmacokinetics. Further, the 90%CI of the mean ratios of the test versus the reference formulations of log-transformed area under the concentration-time curve over 72 hours (93% to 107%) and peak concentration (92% to 108%) were within the acceptable range of 80% to 125%. Based on the obtained results, the test formulation of teriflunomide could be similar to that of the reference formulation. |
| Databáze: | OpenAIRE |
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