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CompletedNCT00893542Updated Jan 23, 2018

Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions

An interventional study of Mycophenolate Mofetil in Prophylaxis of Organ Rejection, sponsored by Roxane Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Roxane Laboratories · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fasted conditions.

02

Conditions studied

  • Prophylaxis of Organ Rejection
03

In context

Lead sponsor

Roxane Laboratories is the lead sponsor of 98 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion criteria

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Interventions

  • DrugMycophenolate Mofetil

    mycophenolate mofetil 250 mg capsule

    Also known as: CellCept

06

What researchers measure

Primary outcomes

  1. bioequivalence determined by statistical comparison Cmax

    Time frame: baseline, 2-period, 14 day washout

07

Study locations

1 site
  • CEDRA Clinical Research, LLC
    Austin, Texas 78759, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00893542
Lead sponsor
Roxane Laboratories
First posted
May 6, 2009
Start date
Nov 2005
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Jan 23, 2018

Study contacts

William Allen Alexander, M.D.
principal investigator · CEDRA Clinical Research, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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