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

NCT01190748 | Completed Phase 1

• 1 other identifier: 40463
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to compare the rate and extent of absorption of Purepac, a subsidiary of Alpharma Inc., U.S.A., galantamine and Janssen Pharmaceutica Products, L.P., U.S.A. (Reminyl),galantamine, administered as a 1 x 4 mg tablet, under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Galantamine; Reminyl; Galantamine hydrobromide; Healthy 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 dose DRUG

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

Also known as: Galantamine

A

Reminyl 4 mg Tablet, single dose DRUG

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

Also known as: Galantamine hydrobromide

B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• Capable of consent.
• BMI2:19.0 and \<30.0 kg/rn".

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.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

SFBC Anapharm

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

Location

MeSH Terms

Interventions

Galantamine; Tablets

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Benoit Girard, M.D.

  SFBC Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 30, 2010
• Study Start: November 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

CA (1)