Back to resultsGalantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition
Primary Purpose
Fed
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Reminyl
Sponsored by
About this trial
This is an interventional treatment trial for Fed
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Galantamine
Reminyl
Arm Description
Galantamine Hydrobromide Tablets of Dr. Reddy's
Reminyl 4 mg tablets of Janssen Pharmaceutical Products
Outcomes
Primary Outcome Measures
Bioequivalence on Cmax and AUC parameters
Secondary Outcome Measures
Full Information
NCT ID
NCT01372306
First Posted
January 27, 2011
Last Updated
June 29, 2011
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT01372306
Brief Title
Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition
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 Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
October 2004
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fed condition.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Galantamine
Arm Type
Experimental
Arm Description
Galantamine Hydrobromide Tablets of Dr. Reddy's
Arm Title
Reminyl
Arm Type
Active Comparator
Arm Description
Reminyl 4 mg tablets of Janssen Pharmaceutical Products
Intervention Type
Drug
Intervention Name(s)
Reminyl
Other Intervention Name(s)
Reminyl 4 mg
Intervention Description
Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited
Primary Outcome Measure Information:
Title
Bioequivalence on Cmax and AUC parameters
Time Frame
2 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaerano Morelli
Organizational Affiliation
Early Clinical Research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition
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