Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fasting Condition

NCT01080443 | Completed

• 1 other identifier: 328-07
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to compare the bioavailability and characterise the pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA in normal, healthy, adult human subjects under fasting conditions, and to assess the bioequivalence.

Conditions

Healthy Volunteers

Keywords

Bioequivalence study in healthy volunteers

Outcome Measures

Primary Outcomes (1)

• To compare the bioavailability of Mycophenolate mofetil 250 mg capsules Panacea Biotec Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA, and to assess the bioequivalence.

  up to 3 days

Study Arms (2)

Cellcept® 250 mg Capsule

ACTIVE COMPARATOR

Drug: Mycophenolate Mofetil Capsule 250 mg

Mycophenolate Mofetil Capsule 250 mg

EXPERIMENTAL

Drug: Mycophenolate Mofetil Capsule 250 mg

Interventions

Mycophenolate Mofetil Capsule 250 mg DRUG

Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule

Also known as: Mycophenolate Mofetil Capsule

Cellcept® 250 mg Capsule; Mycophenolate Mofetil Capsule 250 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal, healthy human volunteers between 18 and 60 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
• Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg / height in m2.
• Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12 - lead ECG and X-ray chest (postero-anterior view) recordings.
• Able to comply with study procedures, in the opinion of the Principal Investigator.
• Able to give written consent for participation in the trial.
• In case of female subjects they must be (A) Surgically sterilized at least 6 months prior to study participation or (B) Those who are of child bearing potential must be using a suitable and effective double barrier contraceptive method or intra urine devices during the study.

You may not qualify if:

• Known hypersensitivity or idiosyncratic reaction to Mycophenolate Mofetil or any related drug.
• Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
• Ingestion of a medicine at any time in 14 days before the start of the study. In any such case subject selection will be at the discretion of the Principal Investigator / Medical Expert.
• Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or nonsteroidal anti-inflammatory drug (NSAID) induced urticaria.
• A recent history of alcoholism (\<2 years) or of moderate (180 mL / day) alcohol use, or consumption of alcohol within 48 hour prior to receiving study medicine.
• Smokers, who smoke 10 or more cigarettes per day and / or unable to abstain from smoking during the study.
• The presence of clinically significant abnormal laboratory values during screening.
• Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scan.
• History of psychiatric disorders.
• A history of difficulty in donating blood.
• Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.
• Note: In case the blood loss is ≤ 200 mL, subject may be dosed 60 days after blood donation.
• A positive hepatitis screen including hepatitis B surface antigen and anti-hepatitis C virus (HCV) antibodies.
• A positive test result for anti-HIV antibody and / or syphilis.
• Note: If subject had participated in a study in which blood loss is ≤ 200 mL, subject can be dosed 60 days after the last sample of previous study.

Sponsors & Collaborators

• Panacea Biotec Ltd: lead

Study Sites (1)

Lambda Therapeutic Research Ltd.

Ahmedabad, Gujarat, 380 061, India

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr. Pankaj K Jha

  Lambda Therapeutic Research Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 4, 2010
• Study Start: June 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 12, 2010

Record last verified: 2010-03

Locations

IN (1)