Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions

NCT00911274 | Completed Phase 1 Results

• 1 other identifier: 20-982-AU
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to compare the oral bioavailability of an investigational formulation of mycophenolate mofetil (MMF) 250 mg capsules to an equivalent dose of the commercially available reference product, CellCept® (mycophenolate mofetil) 250 mg administered to healthy subjects following an overnight fast of at least 10 hours.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration

  Bioequivalence based on Cmax

  Blood samples collected over 72 hour period

• AUC0-inf - Area Under Concentration-time Curve From Time Zero to Infinity (Extrapolated)

  Bioequivalence based on AUC0-inf

  Blood samples collected over 72 hour period

• AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration

  Bioequivalence based on AUC0-t

  Blood samples collected over 72 hour period

Study Arms (2)

Test (mycophenolate mofetil) First

EXPERIMENTAL

Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.

Drug: Mycophenolate Mofetil

Reference (CellCept®) First

ACTIVE COMPARATOR

CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.

Drug: CellCept®

Interventions

Mycophenolate Mofetil DRUG

250 mg Capsule

Test (mycophenolate mofetil) First

CellCept® DRUG

250 mg Capsule

Reference (CellCept®) First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must satisfy the following criteria to be considered for study participation:
• Subject must be male or non-pregnant, non-breast-feeding female
• Subject must be at least 18 years of age
• Subject must have a Body Mass Index (BMI) between 19 and 30 kg/m2, inclusive, and body weight should be at least 50 kg (110 lbs)
• Female Subjects - not surgically sterile or at least two years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, double barrier (condom with spermicide, diaphragm with spermicide), intra-uterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
• Subject must voluntarily consent to participate in this study and provide their written informed consent prior to the start of any study-specific procedures.
• Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return for any outpatient visits.

You may not qualify if:

• Subjects may be excluded for any of the following:
• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
• Has a clinically significant abnormal finding on the physical exam, medical history, ECG or clinical laboratory results at screening.
• History or presence of allergic or adverse response to mycophenolate mofetil or related drugs.
• Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
• Has donated blood or plasma within 30 days prior to the first dose of study medication.
• Has participated in another clinical trial within 30 days prior to the first dose of study medication.
• Has used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
• Has used any prescription medication, including hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
• Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
• Has smoked or used tobacco products within 90 days prior to the first dose of study medication.
• Is a female with a positive pregnancy test result.
• Female who has used implanted hormonal contraceptives anytime during the 6 months prior to study start.
• Has an intolerance to venipuncture.
• Has difficulty fasting or consuming standard meals.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Cedra Clinical Research, LLC

Austin, Texas, 78759, United States

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: TEVA Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Frederick A Bieberdorf, MD

  Cedra Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: June 1, 2009
• Study Start: October 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: August 19, 2024
• Results First Posted: September 23, 2009

Record last verified: 2024-08

Locations

US (1)