NCT01513057

Brief Summary

An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in healthy, adult, human, male subjects under fed conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

Same day

First QC Date

January 16, 2012

Last Update Submit

January 19, 2012

Conditions

Healthy

Keywords

bioequivalenceMycophenolate Mofetilcrossover

Outcome Measures

Primary Outcomes (1)

  • Area Under Curve (AUC)

    pre-dose, 0.167, 0.333,. 0.500, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 hours post dose

Study Arms (2)

Mycophenolate Mofetil

EXPERIMENTAL

Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited

Drug: Mycophenolate Mofetil

Cellcept

ACTIVE COMPARATOR

Cellcept 250 mg capsules of Roche Laboratories Inc.

Drug: Mycophenolate Mofetil

Interventions

Mycophenolate MofetilDRUG

Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited

Mycophenolate Mofetil

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, adult, human male volunteers between 18 - 55 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 - 24.9 (both inclusive), calculated as weight in kg/height in meter2.
  • Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest recordings.
  • Able to comply with the study procedures, in the opinion of the Principal investigator.
  • Able to give voluntary written informed consent for participation in the study.

You may not qualify if:

  • Known hypersensitivity or idiosyncratic reaction to Mycophenolate mofetil or any related drug.
  • Any disease or condition that compromised the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
  • Ingestion of a medicine at any time with in 14 days before dosing in Period-I. In any such case subject selection was at the discretion of the Principal Investigator.
  • Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
  • A recent history of alcoholism (\< 2 years) or of moderate (180 mL/day) alcohol use, or consumption of alcohol within 48 hours prior to receiving study medicine.
  • Smokers, who smoked 10 or more than 10 cigarettes/day or inability to abstain from smoking during the study.
  • Consumption of Grapefruits or its products within a period of 48 hours prior to dosing.
  • 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 scans.
  • History of psychiatric disorders.
  • A history of difficulty with donating blood.
  • Note: If subject had participated in a study in which blood loss was ≤ 200 mL, subject could be enrolled 60 days after the last sample of previous study.
  • A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies.
  • A positive test result for HIV antibody and/or syphilis.
  • An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine and throughout the subjects' participation in the study. In any such case subject selection was at the discretion of the Principal Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lambda Therapeutic Research Ltd

Ahmedabad, Gujarat, 3 80 061, India

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Pankaj Kumar Jha, MD

    Lambda Therapeutic Research Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 20, 2012

Study Start

January 1, 2009

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

IN(1)