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.

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. - SSP-002358/omeprazole DDI study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35226

Enrollment

Registered

2011-08-01

Start date

2011-08-31

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroesophageal reflux disease

Interventions

Study Medication Active substance: SSP-002358 Activity : 5-HT4 receptor agonist Indication : gastroesophageal reflux disease Strength : 0.5 mg Dosage form: tablets Active substance: omeprazole A

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18 - 55 year, BMI 18.5 - 30.0 kg/m2; no smoking.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Criteria for evaluation Pharmacokinetics: pharmacokinetic parameters for SSP-002358 Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)