Study of the rate of absorption of donepezil 10mg in the form of an orodispersible film versus donepezil 10mg in the form of an orodispersible tablet in healthy subjects under fasting conditions

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2012
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. CONDITION: Alzheimer's disease ; Mental and Behavioural Disorders ; Alzheimer's disease PRIMARY OUTCOME: 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: 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 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 leas
Epistemonikos ID: b8927816c6cbb7e837c4e44ddb1adeb8ea4d902c
First added on: Aug 22, 2024