A Phase 1, Open-Label, Single-Dose, Three-Period, Randomized Study Comparing the Pharmacokinetics of Cysteamine Bitartrate Delayed-Release Capsules Following Oral Administration with Orange Juice, Water, or Omeprazole in Healthy Adult Subjects
Phase of Trial: Phase I
Latest Information Update: 16 Feb 2018
At a glance
- Drugs Mercaptamine bitartrate (Primary) ; Omeprazole
- Indications Nephropathic cystinosis
- Focus Pharmacokinetics
- Sponsors Horizon Pharma
- 16 Feb 2018 New trial record
- 06 Feb 2018 Primary endpoint (Maximum observed concentration (Cmax)) has been met, according to results published in the Advances in Therapy Journal.
- 06 Feb 2018 Primary endpoint (Area under the concentrationtime curve from time 0 extrapolated to infinity (AUC0-infinity)) has been met, according to results published in the Advances in Therapy Journal.