Bioequivalence Study of Rivastigmine 1.5 mg Capsules Under Fasting Conditions

NCT01146067 | Completed Phase 1

• 1 other identifier: 30496
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a bioequivalence study of Rivastigmine 1.5 mg capsules and Exelon Administered as 1.5 mg capsule in Healthy subjects under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  2 months

Study Arms (2)

Rivastigmine

EXPERIMENTAL

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

Drug: Rivastigmine

Exelon

ACTIVE COMPARATOR

Exelon 1.5 mg capsules of Novartis

Drug: Rivastigmine

Interventions

Rivastigmine DRUG

Rivastigmine capsules 1.5 mg

Also known as: Exelon 1.5 mg capsules

Exelon; Rivastigmine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Web site, Anapharm volunteers' 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.

You may not qualify if:

• 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 H, 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 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
• BMI2: 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Interventions

Rivastigmine

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Richard Larouche, M.D

  Anapharm Inc, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: June 17, 2010
• Study Start: January 1, 2004
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: January 13, 2012

Record last verified: 2010-06