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

NCT ID: NCT01372280

Last Updated: 2011-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2004-11-30

Brief Summary

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

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

Conditions

Fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Galantamine

Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited

Group Type: EXPERIMENTAL

Reminyl

Intervention Type: DRUG

Galantamine Hydrobromide Tablets 4 mg

Reminyl

Reminyl 4 mg tablets of Janssen Pharmaceutical Products

Group Type: ACTIVE_COMPARATOR

Reminyl

Intervention Type: DRUG

Galantamine Hydrobromide Tablets 4 mg

Interventions

Reminyl

Galantamine Hydrobromide Tablets 4 mg

Intervention Type: DRUG

Other Intervention Names

Reminyl 4 mg

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Reddy's laboratories Limited

Principal Investigators

Gaerano Morelli

Role: PRINCIPAL_INVESTIGATOR

Early Clinical Research

Other Identifiers

AA21896

Identifier Type: -

Identifier Source: org_study_id