Condition category
Mental and Behavioural Disorders
Date applied
07/02/2012
Date assigned
14/03/2012
Last edited
14/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Denis Audet

ORCID ID

Contact details

Pharmanet
2500
Rue Einstein
Quèbec
G1P 0A2
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

110559

Study information

Scientific title

Randomised, open-label, 2-way crossover bioequivalence study of donepezil 10mg orodispersible film versus donepezil 10mg orodispersible tablet in healthy subjects under fasting conditions

Acronym

Study hypothesis

Compare the rate and extent of absorption of donepezil 10 mg orodispersible film (test) versus Aricept Evess orodispersible tablet (control), administered without water under fasting conditions.

Ethics approval

Institutional Review Board/CTA approval ref: 9427-A2419-21C

Study design

Single centre open-label randomised single-dose crossover study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alzheimer's disease

Intervention

Donepezil Renantos 10 mg orodispersible film, only one administration per subject without water under fasting conditions. Blood collections will be during the 72 hours after administration.

Aricept Evess 10 mg orodispersible tablets, only one administration per subject without water under fasting conditions. Blood collections will be during the 72 hours after administration.

Intervention type

Drug

Phase

Not Applicable

Drug names

Donepezil

Primary outcome measures

In each period, a total of 18 blood samples will be drawn from each subject for pharmacokinetic analyses. Blood samples will be collected prior to drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36, 48, and 72 hours post-dose (3 mL for each sampling time).

Blood pressure and heart rate will also be measured prior to dosing and approximately 2, 4, 8, and 24 hours post-dose. Oral temperature will be measured at screening and at study exit.

A urine drug screen (amphetamines, methamphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol, cocaine, opiates, phencyclidine, MDMA, methadone) and a urine cotinine test will be performed at screening. A urine drug screen, a urine cotinine test, and an alcohol breath test will be performed before dosing of each period

Secondary outcome measures

1. Blood pregnancy
2. Test demographic datamedical and medication histories
3. Physical examination
4. Body measurements
5. Electrocardiogram (12-lead ECG)
6. Vital signs (blood pressure, heart rate, and respiratory rate)
7. Oral temperature
8. Hematology - HIV, hepatitis B and C tests
9. Biochemistry
10. Urinalysis
11. Urine cotinine test
12. Urine pregnancy test
13. Urine drug screen

Overall trial start date

01/02/2012

Overall trial end date

15/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female participants
2. Non-smokers
3. Aged between 18 and 55 years of age
4. BMI between 18.5 and < 30.0
5. Healthy as defined by:
5.1. The absence of clinically significant illness and surgery within 4 weeks prior to dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Qualified Investigator.
5.2. The absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
6. Females of childbearing potential who are sexually active must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after:
6.1. Intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration
6.2. Condom or diaphragm and spermicide starting at least 14 days prior to study drug administration
6.3. Hormonal contraceptives starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study
6.4. Sterile male partner (vasectomized since at least 6 months)
7. Capable of consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 healthy adult male and female, non-smokers

Participant exclusion criteria

1. Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening
2. Positive urine drug screen or urine cotinine test at screening
3. History of allergic reactions to donepezil, piperidine derivates, dimenhydrinate or derivatives, or other related drugs
4. Use of any drugs known to induce or inhibit CYP 2D6 or CYP 3A4 within 30 days prior to administration of the study medication
5. Positive pregnancy test at screening
6. Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study
7. Clinically significant ECG abnormalities 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
8. History of significant alcohol abuse within one year prior to screening or 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])
9. History of significant drug abuse within one year prior to screening or 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 screening
10. Use of an investigational drug within 30 days (90 days for biologics) or participation in an investigational study within 30 days prior to dosing
11. Use of medication other than topical products without significant systemic absorption and hormonal contraceptives:
11.1. Prescription medication within 14 days prior to the first dosing
11.2. Over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2g daily)
11.3. A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to the first dosing
12. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing
13. Hemoglobin <128 g/L (males) and <115 g/L (females) and hematocrit <0.37 L/L (males) and <0.32 L/L (females) at screening
14. Breast-feeding subject
15. Presence of tongue piercing or braces at the time of dosing
16. Clinically significant abnormal laboratory values at screening. Note: Eosinophils, Neutrophils and Lymphocytes values must not go over 1.5 times the upper limit of normal.

Recruitment start date

01/02/2012

Recruitment end date

15/03/2012

Locations

Countries of recruitment

Canada

Trial participating centre

Pharmanet
Quèbec
G1P 0A2
Canada

Sponsor information

Organisation

Applied Pharma Research [APR] (Switzerland)

Sponsor details

Via Corti 5
Balerna
CH - 6828
Switzerland

Sponsor type

Industry

Website

http://www.apr.ch/

Funders

Funder type

Industry

Funder name

Applied Pharma Research [APR] (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes