SSP-002358 Drug Interaction Study With Omeprazole
This study has been completed.
Information provided by (Responsible Party):
First received: August 10, 2011
Last updated: June 1, 2012
Last verified: June 2012
This is a drug interaction study evaluating whether blood plasma concentrations of SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Open-label, Randomized, 2-period Crossover Drug Interaction Study in Healthy Adult Subjects to Evaluate the Effect of the Proton Pump Inhibitor Omeprazole on the Pharmacokinetics of SSP-002358|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Shire-Movetis NV:
Primary Outcome Measures:
- Maximum Plasma Concentration (Cmax) for SSP-002358 [ Time Frame: Assessed over 48 hours post-dose ] [ Designated as safety issue: No ]Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
- Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358 [ Time Frame: Assessed over 48 hours post-dose ] [ Designated as safety issue: No ]Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
|Study Start Date:||August 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|Experimental: SSP-002358 alone||
1 mg, oral, once
Experimental: SSP-002358 + omeprazole
SSP-002358 + omeprazole
Drug: SSP-002358 + omeprazole
SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once
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