Bioequivalence Study of Rivastigmine 1.5 mg Capsules Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01146067
First received: February 10, 2010
Last updated: January 12, 2012
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Rivastigmine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioequivalence Study of Rivastigmine 1.5 mg Capsules (Test)of Dr.Reddy's Laboratories Limited Versus Exelon (Reference),Administered as 1 x 1.5 mg Capsule Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2004
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivastigmine
Rivastigmine capsules 1.5 mg of Dr.Reddy's Laboratories Limited
Drug: Rivastigmine
Rivastigmine capsules 1.5 mg
Other Name: Exelon 1.5 mg capsules
Active Comparator: Exelon
Exelon 1.5 mg capsules of Novartis
Drug: Rivastigmine
Rivastigmine capsules 1.5 mg
Other Name: Exelon 1.5 mg capsules

Detailed Description:

Single center, bioequivalence, open-label, randomized, 2-way crossover study administered as 1 x 1.5 mg capsule in healthy subjects under fasting conditions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.

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 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.
  • 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 energy, 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,
  • 300 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146067

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Richard Larouche, M.D Anapharm Inc, Canada
  More Information

No publications provided

Responsible Party: Sr.Manager -R&D, Dr.Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01146067     History of Changes
Other Study ID Numbers: 30496
Study First Received: February 10, 2010
Last Updated: January 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence

Additional relevant MeSH terms:
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014