HealthyPhase 1NCT01276080
Bioequivalence Study of Donepezil Hydrochloride 10 mg Tablets Under Fed Conditions
A Phase 1 study testing Donepezil in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
Trial summary
This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover study was conducted to compare the relative bioavailability of equal doses of the test and reference products under non-fasted conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females, 18 to 65 years of age (inclusive) and a Body Mass Index (BMI) 18 to 30 kg/m² inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures
- Female subjects of child bearing potential must either abstain from sexual intercourse, or use a reliable non-hormonal method of contraception (e.g. condom with spermicide, IUD) for at least 30 days prior to dosing and during the duration of the study. The use of any type of hormonal contraception is not allowed.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed and dated informed consent form, which meets all criteria of current FDA regulations.
Who cannot join
- Females who are pregnant, lactating or likely to become pregnant during the study
- History of allergy or sensitivity to donepezil, other cholinesterase inhibitors, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
- Presence of gastrointestinal disease or history of malabsorption within the last year. Any history of gastrointestinal ulcers, bleeding or obstruction.
- History of asthma or obstructive pulmonary disease.
- History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
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- Presence of a medical condition requiring regular treatment with prescription drugs (including hormonal contraceptives).
- Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
- Receipt of any drug as part of a research study within 30 days prior to dosing.
- Drug or alcohol addiction requiring treatment in the past 12 months.
- Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
- Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
- Positive test results for drugs of abuse or alcohol at screening.
- Positive serum pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novum Pharmaceutical Research Services
Las Vegas, Nevada, 89121
About this study
Official title: A Study to Evaluate A Study to Evaluate the Relative Bioavailability of Donepezil Hydrochloride 10 mg Tablets (OHM Laboratories, Inc., USA) Compared to ARICEPT® (Donepezil Hydrochloride)10 mg Tablets (Eisai Inc.) in Healthy Volunteers Under Non-Fasted Conditions
This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover study was conducted to compare the relative bioavailability of equal doses of the test and reference products under non-fasted conditions.
Read the detailed description
This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover study was conducted to compare the relative bioavailability of equal doses of the test and reference products under non-fasted conditions. The study was conducted with 36 (31 completing) healthy adults in accordance with Protocol No. 10940308 (Revision 0). In each study period, a single 10 mg tablet of donepezil hydrochloride was administered to all subjects following a standardized high fat, high calorie breakfast, preceded by an overnight fast of at least 10 hours. The test formulation was donepezil hydrochloride 10 mg tablet (OHM Laboratories, Inc., USA a subsidiary of Ranbaxy Pharmaceuticals, Inc. USA) and the reference formulation was ARICEPT® (donepezil hydrochloride) 10 mg Tablets (Eisai Inc.). The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. Subjects were confined at the clinical facility from at least 10.5 hours prior to dosing until after the 24 hour blood collection. Subjects returned to the clinical facility for the 36, 48, and 72 hour blood sample collection. There was a 28-day interval between treatments.
Blood samples were collected pre-dose and at intervals over 72 hours after dosing in each period. The plasma samples from all subjects were shipped to Warnex Bioanalytical Services for determination of donepezil concentrations.
Statistical analysis was performed by Ranbaxy Laboratories Limited to compare the bioequivalence of the test formulation to the reference product. Bioequivalence was determined based on the confidence intervals for the major pharmacokinetic parameters, AUC0-72 and Cmax, for donepezil.
- Conditions
- Healthy
- Being tested
- Donepezil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
10 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Donepezil Hydrochloride 10 mg Tabletof OHM Laboratories, Inc. Receives: Drug: Donepezil |
| 2 | Active comparator | ARICEPT® (donepezil hydrochloride) 10 mg Tablet of Eisai, Inc. Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence evaluation of Donepezil 10mg tablets
Measured: completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276080
- Sponsor's protocol ID
- 10940308
- Status last verified
- Jun 2012
- First submitted
- 11 Jan 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate A Study to Evaluate the Relative Bioavailability of Donepezil Hydrochloride 10 mg Tablets (OHM Laboratories, Inc., USA) Compared to ARICEPT® (Donepezil Hydrochloride)10 mg Tablets (Eisai Inc.) in Healthy Volunteers Under Non-Fasted Conditions
- ClinicalTrials.gov ID
- NCT01276080
- Acronym / sponsor ID
- 10940308
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover study was conducted to compare the relative bioavailability of equal doses of the test and reference products under non-fasted conditions.
Detailed description
This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover study was conducted to compare the relative bioavailability of equal doses of the test and reference products under non-fasted conditions. The study was conducted with 36 (31 completing) healthy adults in accordance with Protocol No. 10940308 (Revision 0). In each study period, a single 10 mg tablet of donepezil hydrochloride was administered to all subjects following a standardized high fat, high calorie breakfast, preceded by an overnight fast of at least 10 hours. The test formulation was donepezil hydrochloride 10 mg tablet (OHM Laboratories, Inc., USA a subsidiary of Ranbaxy Pharmaceuticals, Inc. USA) and the reference formulation was ARICEPT® (donepezil hydrochloride) 10 mg Tablets (Eisai Inc.). The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. Subjects were confined at the clinical facility from at least 10.5 hours prior to dosing until after the 24 hour blood collection. Subjects returned to the clinical facility for the 36, 48, and 72 hour blood sample collection. There was a 28-day interval between treatments.
Blood samples were collected pre-dose and at intervals over 72 hours after dosing in each period. The plasma samples from all subjects were shipped to Warnex Bioanalytical Services for determination of donepezil concentrations.
Statistical analysis was performed by Ranbaxy Laboratories Limited to compare the bioequivalence of the test formulation to the reference product. Bioequivalence was determined based on the confidence intervals for the major pharmacokinetic parameters, AUC0-72 and Cmax, for donepezil.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DonepezilDonepezil Hydrochloride 10 mg Tabletof OHM Laboratories, Inc. |
| 2 | Active comparator | Drug: DonepezilARICEPT® (donepezil hydrochloride) 10 mg Tablet of Eisai, Inc. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, 18 to 65 years of age (inclusive) and a Body Mass Index (BMI) 18 to 30 kg/m² inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures
- Female subjects of child bearing potential must either abstain from sexual intercourse, or use a reliable non-hormonal method of contraception (e.g. condom with spermicide, IUD) for at least 30 days prior to dosing and during the duration of the study. The use of any type of hormonal contraception is not allowed.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed and dated informed consent form, which meets all criteria of current FDA regulations.
Key exclusion criteria (14 listed)
- Females who are pregnant, lactating or likely to become pregnant during the study
- History of allergy or sensitivity to donepezil, other cholinesterase inhibitors, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
- Presence of gastrointestinal disease or history of malabsorption within the last year. Any history of gastrointestinal ulcers, bleeding or obstruction.
- History of asthma or obstructive pulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil10 mg tablets | Drug | 1, 2 |
Primary outcome
Bioequivalence evaluation of Donepezil 10mg tablets
Time frame: completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Donepezil in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence evaluation of Donepezil 10mg tablets (time frame: completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.