Interventions Treatment sequences (A-B or B-A). Treatment A: EC-MPS 720 mg 12 hour for 21 days. Treatment B MMF 1000 mg 12 hourly for 21 days. Drugs were administered one hour before meals. Cyclosporine and prednisone doses were kept constant over the course of the study and were taken concomitantly with the study medication, whereas other co medications were ingested four hours apart. Drug administration prior to PK testing drugs was after a 12 hour fast. Outcomes MPA plasma levels were measured over the seven consecutive days at 1, 0, 1, 2, and 3 h after the morning MPA dose using validated high performance liquid chromatography method. Random sequence Unclear generation (selection bias) Allocation concealment Unclear (selection bias) Blinding (performance Unclear bias and detection bias) Self-reported outcomes Blinding (performance Unlikely and detection bias) Objective outcomes Incomplete outcome data Unlikely (attrition bias) Selective reporting No for PK. Possibly for AEs (reporting bias) Other bias (include Novartis study funding) Ethics and GCP The trial was performed in accordance with the amended Declaration of Helsinki.
Interventions Treatment sequences (A-B or B-A). Treatment A: EC-MPS 720 mg 12 hour for 21 days. Treatment B MMF 1000 mg 12 hourly for 21 days. Drugs were administered one hour before meals. Cyclosporine and prednisone doses were kept constant over the course of the study and were taken concomitantly with the study medication, whereas other co medications were ingested four hours apart. Drug administration prior to PK testing drugs was after a 12 hour fast. Outcomes MPA plasma levels were measured over the seven consecutive days at 1, 0, 1, 2, and 3 h after the morning MPA dose using validated high performance liquid chromatography method. Random sequence generation (selection bias) Unclear Allocation concealment (selection bias) Unclear Blinding (performance bias and detection bias) Self-reported outcomes Unclear Blinding (performance and detection bias) Objective outcomes Unlikely Incomplete outcome data (attrition bias) Unlikely Selective reporting (reporting bias) No for PK. Possibly for AEs Other bias (include funding) Novartis study Ethics and GCP The trial was performed in accordance with the amended Declaration of Helsinki.
auspar-mycophenolate-sodium-130517-cer.docx