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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372280
• Other study ID #: AA21896
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2011
• Last updated: June 29, 2011
• Start date: October 2004
• Est. completion date: November 2004

Study information

• Verified date: January 2011
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasting

Intervention

Drug:
• Reminyl
Galantamine Hydrobromide Tablets 4 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence on Cmax and AUC parameters		2 Months	No