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A Pharmacokinetic Study to Assess the Single-Dose Bioequivalence of a Potential Generic Formulation of a 6-Mercaptopurine 50 mg Tablet Compared to a Marketed 6-Mercaptopurine 50 mg Tablet, Purinethol®, When Administered to Healthy Male Subjects, in the Fasted State


N/A
18 Years
45 Years
Not Enrolling
Male
Acute Lymphoblastic Leukemia

Thank you

Trial Information

A Pharmacokinetic Study to Assess the Single-Dose Bioequivalence of a Potential Generic Formulation of a 6-Mercaptopurine 50 mg Tablet Compared to a Marketed 6-Mercaptopurine 50 mg Tablet, Purinethol®, When Administered to Healthy Male Subjects, in the Fasted State


Inclusion Criteria:



- No clinically significant abnormal findings on physical examination, medical history,
or clinical laboratory results.

- Must voluntarily consent.

Exclusion Criteria:

- Must not have a known history of thiopurine methyltransferase deficiency or family
history.

- Must not have a history of elevated uric acid or gout.

- Must not be currently using allopurinol.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Bioequivalence

Outcome Time Frame:

Baseline, two period, 3 day washout

Safety Issue:

No

Principal Investigator

Mark J Allison, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MDS Pharma Services

Authority:

United States: Food and Drug Administration

Study ID:

439-09

NCT ID:

NCT00602134

Start Date:

November 2002

Completion Date:

November 2002

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location
MDS Pharma Services Phoenix, Arizona  85044