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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01372306
Other study ID # AA21897
Secondary ID
Status Completed
Phase Phase 1
First received January 27, 2011
Last updated June 29, 2011
Start date October 2004
Est. completion date November 2004

Study information

Verified date October 2004
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 Fed condition.


Description:

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 Fed Conditions


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 2004
Est. primary completion date November 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 studyI 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 Ufe 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 HCV.

- 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


Intervention

Drug:
Reminyl
Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited

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 Yes
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