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.
Completed
- Conditions
- gastroesophageal reflux disease10017943
- Registration Number
- NL-OMON35226
- Lead Sponsor
- Shire-Movetis NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 42
Inclusion Criteria
Age 18 - 55 year, BMI 18.5 - 30.0 kg/m2; no smoking.
Exclusion Criteria
Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Criteria for evaluation<br /><br>Pharmacokinetics: pharmacokinetic parameters for SSP-002358<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>