Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01372280
Other study ID # AA21896
Secondary ID
Status Completed
Phase Phase 1
First received January 25, 2011
Last updated June 29, 2011
Start date October 2004
Est. completion date November 2004

Study information

Verified date January 2011
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 Fasting condition.


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


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date November 2004
Est. primary completion date October 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 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.

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 4 mg

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 No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03754920 - Prolonged Fasting With Meditation and Mild Physical Exercise N/A
Completed NCT05272332 - Gastric Ultrasound Prior to Extubation
Completed NCT04247464 - Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients N/A
Completed NCT01067001 - Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study N/A
Completed NCT00757094 - Safety and Feasibility of Fasting While Receiving Chemotherapy N/A
Completed NCT01506713 - Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions Phase 1
Completed NCT04514380 - Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients
Completed NCT05756868 - The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior N/A
Completed NCT05134207 - The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty N/A
Completed NCT05031598 - Long-term Fasting: Multi-system Adaptations in Humans N/A
Recruiting NCT04501393 - Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients N/A
Enrolling by invitation NCT04027478 - Can Fasting Decrease the Side Effects of Chemotherapy? N/A
Completed NCT05219136 - Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol N/A
Recruiting NCT04625608 - Effect of Premedicant Oral Paracetamol on Gastric Volume and pH Phase 4
Not yet recruiting NCT02562638 - Pre-Procedural Fasting in Cardiac Intervention N/A
Completed NCT01949987 - Does Oral Intake Decreases Postoperative Pain Score in Children N/A
Completed NCT01954836 - Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial N/A
Completed NCT01746719 - Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fasting Condition Phase 1
Completed NCT01831700 - Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions Phase 1
Completed NCT01721187 - Satiety Effects on the Neural Valuation of Food N/A