Fasting Clinical Trial
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
Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fasting condition.
Status | Completed |
Enrollment | 28 |
Est. completion date | November 2004 |
Est. primary completion date | October 2004 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr. Reddy's Laboratories Limited |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bioequivalence on Cmax and AUC parameters | 2 Months | No |
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