MedTrace Logo

Drug-Drug Interaction of Cladribine and Pantoprazole in Multiple Sclerosis Subjects

NCT00938366 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-04-14

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Merck Serono S.A., Geneva

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible, PhD · Merck Serono S.A. - Geneva, an affiliate of MerckKGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-01-31
Completion
2009-01-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00938366 on ClinicalTrials.gov