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

Phase 1

Completed

• Conditions: Fasting
• Interventions: Drug: Reminyl

• Registration Number: NCT01372280
• Lead Sponsor: Dr. Reddy's Laboratories Limited

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

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2004-10
• Study Completion: 2004-11
• Status Verified: 2011-01
• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-13
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Galantamine	Reminyl	Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited
Reminyl	Reminyl	Reminyl 4 mg tablets of Janssen Pharmaceutical Products

Primary Outcome Measures

Name	Time	Method
Bioequivalence on Cmax and AUC parameters	2 Months