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

Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fasting

Intervention: Reminyl (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Gaerano Morelli, Principal Investigator, Affiliation: Early Clinical Research

Summary

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

Clinical Details

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

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

Primary outcome: Bioequivalence on Cmax and AUC parameters

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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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.

Locations and Contacts

Additional Information

Starting date: October 2004
Last updated: June 29, 2011

Page last updated: August 23, 2015

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