Fed
Conditions
Brief summary
Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fed condition.
Detailed description
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
Interventions
DRUGReminyl
Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence on Cmax and AUC parameters | 2 months |
Outcome results
None listed