A Phase 1 interventional study of Donepezil TDS and Aricept in Healthy Subjects, sponsored by Corium, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Corium, Inc. · Phase 1, Interventional, and Other
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Phase 1, open-label, randomized, 3-period, 3-treatment, crossover pharmacokinetic study to evaluate the steady-state pharmacokinetics of 5 mg/day and 10 mg/day Corplex™ Donepezil TDS manufactured with the commercial process compared to 10 mg Aricept® in healthy volunteers.
Screening Period:
Subjects will undergo a Screening Period up to 28 days prior to entering the Treatment Phase.
Treatment Phase consisting of 3 Treatment periods with 3 Treatments A, B, C.
Treatment Period 1: All Subjects will receive Treatment A; 5 mg/day Donepezil Transdermal Delivery System (TDS); 1-week wear and applied for 5 consecutive weeks.
Treatment Periods 2 and 3: Subjects will be randomized (by gender) to receive either sequences of Treatments B-C or Treatments C-B.
Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks Treatment C: 10 mg/day Aricept® donepezil tablet administered daily (QD) for 5 weeks.
Blood samples for pharmacokinetics and safety assessments will be collected during the Treatment Phase.
Corium, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
After resting seated for at least 3 minutes, subjects should be excluded from the study with the following vital signs at Screening
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5 mg/day Donepezil Transdermal Delivery System (TDS) 1-week wear and applied weekly for 5 consecutive weeks
Combination Product: Donepezil TDS
10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks
Combination Product: Donepezil TDS
10 mg/day Aricept® donepezil tablet administered QD for 5 consecutive weeks
Drug: Aricept
Transdermal Delivery System
Oral
Maximum Concentration (Cmax)
To evaluate steady-state donepezil plasma exposure (Cmax) following 5 weeks of treatment.
Time frame: 35 days of each Treatment
Area Under the Curve (AUC)
To evaluate steady-state donepezil plasma exposure (AUC) following 5 weeks of treatment
Time frame: 35 days each Treatment
| Milestone | Treatment Sequence ABC or ACB in Crossover Fashion |
|---|---|
| Started | 60 |
| Completed | 57 |
| Not completed | 3 |
| Withdrew: Physician decision | 2 |
| Withdrew: Failure to follow site rules | 1 |
| Milestone | Treatment Sequence ABC or ACB in Crossover Fashion |
|---|---|
| Started | 55 |
| Completed | 53 |
| Not completed | 2 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | Treatment Sequence ABC or ACB in Crossover Fashion |
|---|---|
| Started | 56 |
| Completed | 53 |
| Not completed | 3 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Failure to follow site rules | 1 |
To evaluate steady-state donepezil plasma exposure (Cmax) following 5 weeks of treatment.
| Cmax ng/ml | Treatment A 5 mg TDS | Treatment B 10 mg TDS | Treatment C 10 mg Oral |
|---|---|---|---|
| Maximum Concentration (Cmax) | 29.9 ± 9.1 | 62.4 ± 19.9 | 70.5 ± 19.4 |
To evaluate steady-state donepezil plasma exposure (AUC) following 5 weeks of treatment
| AUC h*ng/mL | Treatment A 5 mg TDS | Treatment B 10 mg TDS | Treatment C 10 mg Oral |
|---|---|---|---|
| Area Under the Curve (AUC) | 4366.0 ± 1380.1 | 9099.0 ± 2972.1 | 8462.6 ± 2558.0 |
Collected over Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment A - 5 mg TDS | 0/60 (0%) | 0/60 (0%) | 32/60 (53.3%) |
| Treatment B - 10 mg TDS | 0/55 (0%) | 0/55 (0%) | 30/55 (54.5%) |
| Treatment C - 10 mg Oral | 0/56 (0%) | 0/56 (0%) | 32/56 (57.1%) |
| Event | Treatment A - 5 mg TDS | Treatment B - 10 mg TDS | Treatment C - 10 mg Oral |
|---|---|---|---|
| NauseaGastrointestinal disorders | 4/60 | 1/55 | 17/56 |
| Application Site PruritisGeneral disorders | 12/60 | 5/55 | 0/56 |
| DizzinessNervous system disorders | 3/60 | 2/55 | 11/56 |
| ConstipationGastrointestinal disorders | 9/60 | 3/55 | 10/56 |
| HeadacheNervous system disorders | 8/60 | 8/55 | 7/56 |
| DiarrhoeaGastrointestinal disorders | 2/60 | 2/55 | 7/56 |
| SomnolenceNervous system disorders | 0/60 | 0/55 | 6/56 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 4/60 | 5/55 | 5/56 |
| FatigueGeneral disorders | 2/60 | 1/55 | 5/56 |
| Application Site DermatitisGeneral disorders | 5/60 | 3/55 | 1/56 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 39.8 ± 9.91 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 22 |
| Male | 38 |
| Race/Ethnicity, Customized(Participants) | All Study Participants |
|---|---|
| Race — Black of African American | 3 |
| Race — Asian | 1 |
| Race — White | 56 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 60 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2020 to primary completion in Apr 2021, 3 months.
Results were first posted in Sep 2024, 3 years 5 months after primary completion.
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Studies of the drug tested here: Donepezil