Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions

Roxane Laboratories

Status: Completed

Conditions: Prophylaxis of Organ Rejection

Treatments: Drug: mycophenolate mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00893919

MYCO-C250-PVFD-1

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)