Trials / Completed
CompletedNCT00938366
Drug-Drug Interaction of Cladribine and Pantoprazole in Multiple Sclerosis Subjects
An Open-label, Cross Over Study, to Assess the Interactions of Pantoprazole (Proton Pump Inhibitor) With Oral Cladribine Administered in Subjects With Multiple Sclerosis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the influence of pantoprazole on the pharmacokinetic profile of cladribine, especially in terms of extent of absorption of cladribine since pH-modifying drug may potentially affect the stability of cladribine and thereby its bioavailability
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cladribine | Subjects will receive two single doses of 10 mg cladribine orally in either first or second intervention period followed by a washout period of 10-25 days. |
| DRUG | Pantoprazole | Subjects will receive a pantoprazole 40 mg orally for 2 consecutive days either in first or second intervention period. |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2009-01-01
- Completion
- 2009-01-01
- First posted
- 2009-07-13
- Last updated
- 2016-04-14
- Results posted
- 2015-10-20
Source: ClinicalTrials.gov record NCT00938366. Inclusion in this directory is not an endorsement.