Mycophenolate Mofetil Tablets Under Fed Conditions

NCT00908128 | Completed Phase 1 Results

• 1 other identifier: 2006-1264
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to evaluate the comparative bioavailability between Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg Tablets (reference), after a single-dose in healthy subjects under fed conditions.

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 the 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 the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration

  Bioequivalence based on AUC0-t

  Blood samples collected over 72 hour period

Study Arms (2)

Mycophenolate Mofetil (test) First

EXPERIMENTAL

Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.

Drug: Mycophenolate Mofetil

CellCept® (reference) First

ACTIVE COMPARATOR

CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.

Drug: CellCept®

Interventions

Mycophenolate Mofetil DRUG

Mycophenolate Mofetil 500 mg Tablet

Mycophenolate Mofetil (test) First

CellCept® DRUG

CellCept® Tablets, 500 mg

CellCept® (reference) First

Eligibility Criteria

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

You may qualify if:

• Healthy, non-smoking male subjects, 18 years of age or older.
• Healthy, non-smoking post-menopausal or surgically sterile females 18 years of age or older.
• BMI ≥ 19 and ≤ 30.
• Negative for:
• HIV.
• Hepatitis B surface antigen and Hepatitis C antibody.
• Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
• Urine cotinine test
• Serum HCG consistent with pregnancy (females only)
• No significant diseases or clinically significant findings in a physical examination.
• No clinically significant abnormal laboratory values.
• No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
• Be informed of the nature of the study and given written consent prior to receiving any study procedure.
• Females who participate in this study must be unable to have children:
• post-menopausal for at least 1 year - no menstrual cycle for 12 months and LH and FSH levels judged by a physician to be consistent with post-menopausal status.

You may not qualify if:

• Known history or presence of any clinically significant medical condition.
• Known or suspected carcinoma.
• Known or suspected increased susceptibility to infection.
• Known history or presence of active tuberculosis (TB).
• Results of a previous TB skin test greater than 5 mm in diameter.
• Lived in or traveled, during the last 8 weeks, to a country defined by the Public Health Agency of Canada as having WHO estimated sputum smear positive pulmonary TB rate of 15 per 100,000 or higher.
• Known history or presence of:
• Hypersensitivity or idiosyncratic reaction to mycophenolate mofetil and/or any other drug substances with similar activity.
• Alcoholism within the last 12 months.
• Drug dependence and/or substance abuse.
• Use of tobacco or nicotine-containing products within the last 6 months.
• On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
• Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
• Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 499 mL of blood in the previous 45 days OR Donated more than 499 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
• Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Pharma Medica Research Inc.

Toronto, Ontario, M1R 5A3, Canada

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

• Xueyu (Eric) Chen, MD, PhD., FRCP(C)

  Pharma Medica Research, Inc.

  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 22, 2009
• First Posted: May 25, 2009
• Study Start: August 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: August 19, 2024
• Results First Posted: July 21, 2009

Record last verified: 2024-08

Locations

CA (1)