Bioavailability Study of Donepezil Hydrochloride Tablets 23 mg Under Fasting Condition

NCT01923558 | Completed Phase 1 DMC

• 1 other identifier: DNI-P0-652
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate and compare the relative bioavailability and therefore the bioequivalence of two different formulations of donepezil after a single oral dose administration under fasting conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC)

  1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, 24, 48 and 72 hours

Study Arms (2)

Donepezil Hydrochloride Tablets, 23 mg

EXPERIMENTAL

Donepezil Hydrochloride Tablets, 23 mg of Dr.Reddy's Laboratories Ltd

Drug: Donepezil

Aricept

ACTIVE COMPARATOR

Aricept® 23 mg tablet of Eisai Inc

Drug: Donepezil

Interventions

Donepezil DRUG

Donepezil Hydrochloride tablets,23 mg

Also known as: Aricept

Aricept; Donepezil Hydrochloride Tablets, 23 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female volunteer
• Volunteer aged of at least 18 years but not older than 45 years
• Volunteer with a body mass index (BMI) greater than or equal to 21 and below 30 kg/m2
• Volunteer with a body weight greater than or equal to 60 kg.
• Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
• Availability for the entire study period
• Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee.
• Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
• Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)
• Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer

You may not qualify if:

• Seated pulse rate less than 50 bpm at screening
• Seated blood pressure below 105/60 mmHg at screening
• Seated blood pressure below 105/60 mmHg before drug administration
• Females who are pregnant or are lactating
• Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
• History of significant hypersensitivity to donepezil, piperidine derivatives, scopolamine, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
• History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
• Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
• Suicidal tendency, history of or disposition to seizures, state of confusion,clinically relevant psychiatric diseases
• Presence of out-of-range cardiac interval (PR \< 110 msec, PR \> 200 msec, QRS \>110 msec and QTc \> 440 msec) on the screening ECG or other clinically significant ECG abnormalities.
• Use of ASA or NSAIDs (or any product containing ASA or NSAIDs) in the previous 7 days before day 1 of this study
• Use of diphenhydramine in the previous 10 hours before day 1 of this study
• Known presence of rare hereditary problems of galactose and /or lactose intolerance
• Known presence of glaucoma or a predisposition to angle-closure glaucoma

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Algorithme Pharma Inc.

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Eric Sicard, MD

  Algorithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 15, 2013
• Study Start: October 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 15, 2013

Record last verified: 2010-12

Locations

CA (1)