Advertisement

Topics

Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fed Condition

2014-08-27 03:15:29 | BioPortfolio

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 fed conditions, and to assess the bioequivalence.

Description

72 + 12 (stand-by) normal healthy adult subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to High Fat Breakfast half an hour before administration of the study drug and for four (4) additional hours each, post dose during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post dose in each period.A total of 27 blood samples will be withdrawn for pharmacokinetic profiling. The concentration of mycophenolate mofetil and mycophenolic acid will be quantitated using validated LC-MS / MS method.ANOVA, two one-sided tests for bioequivalence, power and ratio analysis for un-transformed and ln-transformed pharmacokinetic parameters Cmax, AUC0-t AUC0-inf will be computed and reported for Mycophenolic acid. Bioequivalence of the test product with that of the reference product under fasting conditions will be concluded if the 90% confidence interval falls within the acceptance range of 80.00-125.00% for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Mycophenolic acid.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy Volunteers

Intervention

Mycophenolate Mofetil Capsule 250 mg

Location

Lambda Therapeutic Research Ltd.
Ahmedabad
Gujarat
India
380 061

Status

Completed

Source

Panacea Biotec Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:29-0400

Clinical Trials [2884 Associated Clinical Trials listed on BioPortfolio]

Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fasting Condition

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®...

Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 (Mycophenolate Mofetil) Tablet

The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the CKD-4101 tablet and Mycophenolate mofetil capsule when administered a...

Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions

The objective of this study was to compare the oral availability of a test product of Mycophenolate Mofetil 250 mg capsule to an equivalent oral dose of the commercially available referenc...

Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults

Coadministration of tacrolimus and mycophenolate mofetil is frequent in kidney transplantation. Due to narrow therapeutic range of tacrolimus and mycophenolate mofetil, therapeutic drug mo...

Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant

The purpose of this study is to evaluate the safety and the tolerability of the substitution of mycophenolate mofetil for enteric-coated mycophenolate sodium in a population of stable rena...

PubMed Articles [4924 Associated PubMed Articles listed on BioPortfolio]

Increased Exposure of Tacrolimus by Co-administered Mycophenolate Mofetil: Population Pharmacokinetic Analysis in Healthy Volunteers.

The objective of the study was to investigate the pharmacokinetic drug-drug interactions between tacrolimus (TAC) and mycophenolate mofetil (MMF) in healthy Korean male volunteers. Seventeen volunteer...

Pharmacokinetics of Mycophenolic Acid after Intravenous Administration of Mycophenolate Mofetil to Healthy Cats.

Mycophenolate mofetil (MMF), the prodrug of mycophenolic acid (MPA), is becoming increasingly popular as an alternative immunosuppressant in feline medicine. Pharmacokinetic information is not availab...

Mycophenolate mofetil, for rheumatic diseases: should we monitor the area under the curve?

Transcriptomic analysis uncovers novel synergistic mechanisms in combination therapy for lupus nephritis.

A recent clinical study showed that combination therapy consisting of mycophenolate mofetil, tacrolimus and steroids was shown to be more effective in achieving complete remission in patients with sev...

Pharmacokinetic Interactions Between Elbasvir/Grazoprevir and Immunosuppressant Drugs in Healthy Volunteers.

Elbasvir (EBR)/grazoprevir (GZR) may be coadministered with immunosuppressant drugs in posttransplant people who are infected with hepatitis C virus. The aim of the present study was to assess the saf...

Medical and Biotech [MESH] Definitions

Persons with no known significant health problems who are recruited to participate in research to test a new drug, device, or intervention as controls for a patient group. (from http://clinicalcenter.nih.gov/recruit/volunteers.html, accessed 2/14/2013)

Hospital or other institutional ethics committees established to consider the ethical dimensions of patient care. Distinguish from ETHICS COMMITTEES, RESEARCH, which are established to monitor the welfare of patients or healthy volunteers participating in research studies.

Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.

Clouding or loss of transparency of the posterior lens capsule, usually following CATARACT extraction.

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

More From BioPortfolio on "Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fed Condition"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Biotechnology - Biotech
"using living things to create products or to do tasks for humans" About Biotechnology - Biotech Biotechnology is the practice of using plants, animals and micro-organisms such as bacteria, as well as biological processes - such as the ripen...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...


Searches Linking to this Trial