Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy

Keywords

BioequivalenceGalantamineReminylGalantamine hydrobromideHealthy subjects

Outcome Measures

Primary Outcomes (1)

Rate and Extend of Absorption
36 hours

Study Arms (2)

A

EXPERIMENTAL

Galantamine 4 mg Tablet, single dose

Drug: Galantamine 4 mg Tablet, single dose

B

ACTIVE COMPARATOR

Reminyl 4 mg Tablet, single dose

Drug: Reminyl 4 mg Tablet, single dose

Interventions

Galantamine 4 mg Tablet, single doseDrug

A: Experimental Subjects received Purepac Pharmaceutical, Company, U.S.A. formulated products under fed conditions

Also known as: Galantamine

Reminyl 4 mg Tablet, single doseDrug

B: Active comparator Subjects received Janssen Pharmaceutica Products,U.S.A., formulated products under fed conditions

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, SFBC Anapharm Web site, SFBC Anapharm volunteers' database). Subjects must meet all of the following criteria in order to be included in the study:
Male or female, smoker or non-smoker, 18 years of age and older

Sponsors & Collaborators

Actavis Inc.
Industrylead

Study Sites (1)

SFBC Anapharm

Sainte-Foy, Quebec, G 1 V 2K8, Canada

MeSH Terms

Interventions

GalantamineTablets

Intervention Hierarchy (Ancestors)

Amaryllidaceae AlkaloidsAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDosage FormsPharmaceutical Preparations

Study Officials

Benoit Girard, M.D.
SFBC Anapharm
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

August 26, 2010

First Posted

August 30, 2010

Study Start

December 2004

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Subjects to whom any of the following applies will be excluded from the study:
Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Any clinically significant abnormality found during medical screening.
Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
Abnormal laboratory tests judged clinically significant.
Positive testing for hepatitis B, hepatitis C, or HN at screening.
ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]).
Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
History of allergic reactions to heparin, galantamine, other tertiary alkaloid derivatives or other related drugs.
Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoine, glucocorticoids, omeprazole; examples of inhibitors: antidepressant (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion ofthe drug.
+23 more criteria

Bioequivalence Study of Galantamine 4 mg Tablet and Reminyl Following a 4 mg Dose in Healthy Subjects Under Fed Conditions

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations