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

NCT01372280 | Completed Phase 1 DMC

• 1 other identifier: AA21896
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

• Bioequivalence on Cmax and AUC parameters

  2 Months

Study Arms (2)

Galantamine

EXPERIMENTAL

Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited

Drug: Reminyl

Reminyl

ACTIVE COMPARATOR

Reminyl 4 mg tablets of Janssen Pharmaceutical Products

Drug: Reminyl

Interventions

Reminyl DRUG

Galantamine Hydrobromide Tablets 4 mg

Also known as: Reminyl 4 mg

Galantamine; Reminyl

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Conditions

Fasting

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gaerano Morelli

  Early Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: June 13, 2011
• Study Start: October 1, 2004
• Primary Completion: October 1, 2004
• Study Completion: November 1, 2004
• Last Updated: June 30, 2011

Record last verified: 2011-01