NCT01513044

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 fasting conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2009

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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 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, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 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 - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects aged between 18 and 50 years (including both).
  • Subjects' weight within the normal range according to normal values for the Body
  • Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.
  • Subjects with clinically acceptable normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
  • Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
  • Subjects having clinically acceptable chest X-Ray (PIA view).
  • Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
  • Subjects having negative alcohol breath test.
  • Subjects willing to adhere to the protocol requirements and to provide written informed consent.

You may not qualify if:

  • The subjects were excluded from the study, if they meet any of the following criteria:
  • Hypersensitivity to Mycophenolate Mofetil or related drugs.
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
  • History or presence of significant alcoholism or drug abuse in the past one year.
  • History or presence of significant smoking (more than 10 cigarettes day or consumption of tobacco products).
  • History or presence of asthma, urticaria or other significant allergic reactions.
  • History or presence of significant gastric and/or duodenal ulceration.
  • History or presence of glaucoma, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm and myasthenia gravis.
  • History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
  • History or presence of cancer.
  • Difficulty with donating blood.
  • Difficulty in swallowing solids like tablets or capsules.
  • Use of any prescribed medication or OTC medicinal products during the last two week prior to initiation of study.
  • Major illness during 3 months before screening.
  • Participation in a drug research study within past 3 months.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

veeda clinical research Pvt. Ltd

Ahmedabad, Gujarat, 3 80 015, India

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Jinesh Shah, MD

    veeda clinical research Pvt. 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

January 1, 2009

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

IN(1)