Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fasting Condition

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01080443
• Date of registration: 02/03/2010
• Primary sponsor: Panacea Biotec Ltd
• Public title: Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fasting Condition
• Scientific title: Open Label Balanced Randomized Two-treatment Two-period Two-sequence Single Dose Two-way Crossover Oral Bioequivalence Study of Mycophenolate Mofetil Capsules 250 mg in Normal Healthy Adult Human Subjects Under Fasting Conditions
• Date of first enrolment: June 2008
• Target sample size: 56
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01080443
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Countries of recruitment

India

Contacts

• Name: Dr. Pankaj K Jha
• Affiliation: Lambda Therapeutic Research Ltd.,

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- The receipt of an investigational product or participation in a drug research study
within a period of 90 days prior to the first dose of study medicine. Elimination
half-life of the study drug should be taken into consideration for inclusion of the
subject in the study.

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.

- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to
receiving the study medication and throughout the subject's participation in the
study. In any such case subject selection will be at the discretion of the Principal
Investigator / Medical Expert.

- Pregnant females or Nursing mothers

- Testing positive in urine pregnancy test.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: Mycophenolate Mofetil Capsule 250 mg

Primary Outcome(s)

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. [Time Frame: up to 3 days]

Secondary ID(s)

328-07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors