- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01146041
Bioequivalence Study of Rivastigmine Capsules 1.5 mg of Dr.Reddy's Under Fed Conditions
June 16, 2010 updated by: Dr. Reddy's Laboratories Limited
Randomized, 2-Way Crossover, Bioequivalence Study of Rivastigmine 1.5 mg Capsules and Exelon Administered as 1 x 1.5 mg Capsule in Healthy Subjects Under Fed Conditions
The purpose of this bioequivalence study is to compare the test of Rivastigmine 1.5 mg Capsules of Dr.Reddy's Laboratories Limited with reference to Exelon 1.5 mg of Novartis in Healthy Subjects Under Fed Conditions.
Study Overview
Detailed Description
Bioequivalence study of Rivastigmine Capsules 1.5 mg and Exelon 1.5 mg This was a single center, single-dose, open-label, randomized, 2-way crossover bioequivalence study,performed under fed conditions.
The treatment phases were separated by a washout period of 7 days.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria
Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, Anapharm Inc. Web site, Anapharm Inc. volunteer's database). Subjects must meet all of the following criteria in order to be included in the study:
- Male or female, smoker or non-smoker, 18 years of age and older.
- Capable of consent
Exclusion criteria
Subjects to whom any of the following applies will be excluded from the study:
- Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the Medical Sub-Investigator,would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Positive testing for hepatitis B, hepatitis C, or HN at screening.
- BCG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mrnHg, or heart rate less than 50 or over 100 bpm) at screening.
- BMI ≥30.0.
- History of significant alcohol abuse within six months prior to the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (l Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine,phencyclidine [PCP]and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
- History of allergic reactions to rivastigmine or other related drugs.
- History of allergic reactions to heparin.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin,ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
- Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption or hormonal contraceptives.
- Difficulty to swallow study medication.
- Smoking more than 25 cigarettes per day.
- Any food allergy, intolerance, restriction or special diet that could, in the opinion of the Medical Sub-Investigator, contraindicate the subject's participation in this study.
- A depot injection or an implant of any drug (other than hormonal contraceptive) within 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
- 50 mL to 300 mL of whole blood within 30 days,
- 301 mL to 500 mL of whole blood within 45 days, or
- more than 500 mL of whole blood within 56 days prior to drug administration.
- History of ulcer disease.
- History of asthma or obstructive pulmonary disease.
- Use of any nonsteroidal anti-inflammatory drugs (e.g. Motrin®, Advil®) within 14 days prior to drug administration.
- History of seizures, urinary obstruction or benign prostatic hypertrophy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rivastigmine
Rivastigmine capsules 1.5 mg of Dr.Reddy's Laboratories Limited
|
Rivastigmine 1.5 mg Capsules
Other Names:
|
Active Comparator: exelon
Exelon 1.5 mg capsules of Novartis
|
Rivastigmine 1.5 mg Capsules
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence based on Cmax and AUC parameters
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Larouche, M.D, Anapharm Inc, Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
February 1, 2004
Study Completion (Actual)
April 1, 2004
Study Registration Dates
First Submitted
February 10, 2010
First Submitted That Met QC Criteria
June 16, 2010
First Posted (Estimate)
June 17, 2010
Study Record Updates
Last Update Posted (Estimate)
June 17, 2010
Last Update Submitted That Met QC Criteria
June 16, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30479
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Rivastigmine
-
Novartis PharmaceuticalsCompleted
-
Novartis PharmaceuticalsCompletedMild to Moderate Alzheimer's DiseaseJapan
-
Novartis PharmaceuticalsCompletedAlzheimer DiseaseUnited States, Germany, Italy, Spain, France, Canada, Switzerland
-
Federal University of BahiaCompletedAlzheimer DiseaseBrazil
-
NovartisCompletedParkinson's Disease DementiaUnited States, Belgium, Italy, United Kingdom, Germany, Australia, Austria, Spain, Canada, France, Netherlands, Turkey, Argentina
-
University of Maryland, BaltimoreFood and Drug Administration (FDA)Completed
-
NovartisCompleted
-
University Hospital TuebingenUnknownDementia | Progressive Supranuclear PalsyGermany
-
NovartisCompletedAlzheimer's DiseaseUnited States