Bioequivalence Study of Rivastigmine Capsules 1.5 mg of Dr.Reddy's Under Fed Conditions

NCT ID: NCT01146041

Last Updated: 2010-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2004-04-30

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rivastigmine

Rivastigmine capsules 1.5 mg of Dr.Reddy's Laboratories Limited

Group Type: EXPERIMENTAL

Rivastigmine

Intervention Type: DRUG

Rivastigmine 1.5 mg Capsules

exelon

Exelon 1.5 mg capsules of Novartis

Group Type: ACTIVE_COMPARATOR

Rivastigmine

Intervention Type: DRUG

Rivastigmine 1.5 mg Capsules

Interventions

Rivastigmine

Rivastigmine 1.5 mg Capsules

Intervention Type: DRUG

Other Intervention Names

Exelon 1.5 mg

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr.Reddy's Laboratories Limited

Principal Investigators

Richard Larouche, M.D

Role: PRINCIPAL_INVESTIGATOR

Anapharm Inc, Canada

Other Identifiers

30479

Identifier Type: -

Identifier Source: org_study_id