Clinical trial NCT01372280: Galantamine Bioequivalence Study of Dr. Reddy's Under Fasting 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 Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fasting
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2011-06-13
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Bioequivalence on Cmax and AUC parameters
timeFrame: 2 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Early Clinical Research
name: Gaerano Morelli
role: PRINCIPAL_INVESTIGATOR
References: