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
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