Status:
COMPLETED
SSP-002358 Drug Interaction Study With Omeprazole
Lead Sponsor:
Shire
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 18-55 years inclusive at the time of consent.
- Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:
- Male, or
- Non-pregnant, non-lactating female
- Females must be at least 90 days post-partum or nulliparous.
- Exclusion criteria:
- Any current or recurrent disease (eg, cardiovascular, renal, liver, gastrointestinal, malignancy or other conditions) that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments.
- Any known or suspected intolerance or hypersensitivity to the investigational product or omeprazole, closely related compounds, or any of the stated ingredients.
Exclusion
Key Trial Info
Start Date :
August 11 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01415349
Start Date
August 11 2011
End Date
September 28 2011
Last Update
June 10 2021
Active Locations (1)
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1
PRA International
Zuidlaren, Netherlands