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Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients

NCT00774982 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2009-07-17

No results posted yet for this study

Summary

The study is being conducted to evaluate the pharmacokinetic parameters (Cmax, Tmax and AUC) of the new delayed release, lowered dose, 40 mg 6MP test formulation as compared to standard 6MP (100 mg Purinethol) in 12 patients with Crohn's Disease.

The study is being undertaken to prove that the new test formulation is indeed delayed-release and targeted to the ileum, and that the levels of 6MP in the blood following local absorption are lower than that seen following standard Purinethol dosing. This should result in lower, safer mercaptopurine dosing, allowing for uninterrupted treatment with fewer side effects.

Conditions

  • Crohns Disease

Interventions

DRUG

Delayed Release 6 mercaptopurine

oral tablet, 1 x 40 mg Delayed Release 6MP tablet, single-dose

DRUG

6 Mercaptopurine

Oral Tablet, 2 x 50 mg 6MP Reference, single-dose

Sponsors & Collaborators

  • Teva GTC

    lead INDUSTRY

Principal Investigators

  • Yaron Ilan, MD · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Israel

Study Locations

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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 NCT00774982 on ClinicalTrials.gov