CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
SSP-002358 +1 moredrug
Likely dose
SSP-002358 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01415349
NCT01415349Phase 1Completed

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

Shire·interventional·Posted Aug 11, 2011·Updated Jun 10, 2021

In Brief

A Phase 1 clinical trial evaluating SSP-002358 and SSP-002358 + omeprazole for Healthy. Completed, enrolled 42 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 11, 2011
Enrollment StartAug 11, 2011
Primary CompletionSep 28, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.9 years ago

Interventions

SSP-002358drug

1 mg, oral, once

SSP-002358 + omeprazoledrug

SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once