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

Study Overview
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Brief Summary
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Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fed condition.

Detailed Description
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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 Fed Conditions

Official Title
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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 Fed Conditions

Conditions
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Fed

Intervention / Treatment
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* Drug: Reminyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the studyI 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 Ufe 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 HCV. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galantamine<br>Galantamine Hydrobromide Tablets of Dr. Reddy's | Drug: Reminyl<br>* Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited<br>* Other names: Reminyl 4 mg;|
| Active Comparator: Reminyl<br>Reminyl 4 mg tablets of Janssen Pharmaceutical Products | Drug: Reminyl<br>* Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited<br>* Other names: Reminyl 4 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence on Cmax and AUC parameters |  | 2 months |