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Galantamine Bioequivalence Study of Dr. Reddy's Under Fasting Condition

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01372280
First received: January 25, 2011
Last updated: June 29, 2011
Last verified: January 2011
History of Changes
  Purpose

Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fasting condition.


Condition Intervention Phase
Fasting
 Drug: Reminyl
 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: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Laboratories, Ltd. and Janssen Pharmaceutical Products, l.P. (Reminyl®)4 mg Galantamine HBr Tablets in Healthy Adult Male Volunteers Under Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

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

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

Enrollment: 28
Study Start Date: October 2004
Study Completion Date: November 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Galantamine
Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited
 Drug: Reminyl
Galantamine Hydrobromide Tablets 4 mg
Other Name: Reminyl 4 mg
Active Comparator: Reminyl
Reminyl 4 mg tablets of Janssen Pharmaceutical Products
 Drug: Reminyl
Galantamine Hydrobromide Tablets 4 mg
Other Name: Reminyl 4 mg

Detailed Description:

Comparative, Randomized, Single-Dose. 2-way Crossover Bioavailability Study of Dr.Reddy's laboratories, ltd. and Janssen Pharmaceutical Products. L.P. (Reminyte®)4 mg Galantamine HBr Tablets In Healthy Adult Male Volunteers under fasting Conditions

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:

  • Healthy adult male volunteers, 18-55 years of age;
  • Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
  • Medically healthy subjects with clinically normal laboratory profiles. vital signs and ECGs;
  • Give voluntary written informed consent to participate in the study.

Exclusion Criteria:

Subject candidates must not be enrolled in the study if they meet any of the following criteria:

  • History or presence of significant cardiovascular, pUlmonary, hepatic, renal, hematologic. gastrointestinal, endocrine, immunologic. dermatologic, neurologic, or psychiatric disease.
  • In addition, history or presence of:
  • alcoholism or drug abuse within the past year;
  • hypersensitivity or idiosyncratic reaction to galantamine or other anticholinesterase inhibitors;
  • asthma and seizures.
  • Subjects who tested positive at screening for HIV, HbsAg or HeV.
  • Subjects whose PR interval is >200 msec at screening and prior to dosing.
  • Subjects whose QTc interval is >450 msec at screening and prior to dosing.
  • Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
  • Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
  • Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.

  • Subjects who, through completion of the study, would have donated in excess of:

    500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 ml of blood in 1 year.

  • Subjects who have participated in another clinical trial within 28 days prior to the first dose.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372280

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Gaerano Morelli Early Clinical Research
  More Information

No publications provided

Responsible Party: Assistant Manager - Research & Development, Dr. Reddy's laboratories Limited
ClinicalTrials.gov Identifier: NCT01372280     History of Changes
Other Study ID Numbers: AA21896
Study First Received: January 25, 2011
Last Updated: June 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Galantamine
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
 Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013