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

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Galantamine

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.