SchizophreniaPhase 1NCT02501109
Comparative Bioavailability Study of Aripiprazole 10 mg Oral Soluble Film vs Abilify® 10 mg Tablet in Healthy Volunteers
A Phase 1 study testing Aripiprazole in people with Schizophrenia, run by CMG Pharmaceutical Co. Ltd.
Trial summary
The purpose of this study is to compare the rate and extent of absorption of Aripiprazole Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male volunteers Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2016
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, moderate smoker (no more than 9 cigarettes daily) or non-smoker, ≥45 and ≤65 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight 50.0 kg for males and 45.0 kg for females.
- Healthy as defined by:
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 42 days after the last study drug administration:
- Capable of consent.
Who cannot join
- 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.
- Positive urine drug screen at screening.
- History of allergic reactions to aripiprazole, dimenhydrinate, benztropine, diphenhydramine or other related drugs.
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration.
- Positive pregnancy test at screening.
- Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
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- Clinically significant electrocardiogram (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), decrease in systolic blood pressure of 20 mmHg or higher, or decrease in diastolic blood pressure of 10 mmHg or higher within 2 to 3 minutes after passing from a supine to a standing position, at screening.
- 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]).
- 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.
- Use of aripiprazole for a medical condition or in the context of another clinical trial within a period of 42 days prior to the first dosing.
- Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics) prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
- Use of medication other than topical products without significant systemic absorption and hormonal contraceptives:
- prescription medication within 14 days prior to the first dosing;
- 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 2 g daily);
- a depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to the first dosing.
- 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 the first dosing.
- 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.
- Breast-feeding subject.
- HAM-D-7 scale score above 3 at screening.
About this study
Official title: A Single-dose, Randomized, Three-period, Crossover Comparative Bioavailability Study of a Novel Formulation of Aripiprazole 10 mg Oral Soluble Film vs the Marketed Formulation Abilify® 10 mg Tablet in Healthy Volunteers
The purpose of this study is to compare the rate and extent of absorption of Aripiprazole Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male volunteers
Read the detailed description
The proposed study is a single centre, bioavailability, open-label, randomized, single-dose, 3-period, 6-sequence, crossover study under fasting conditions. Each volunteer will be given a single dose of the Test formulation in two study periods (with and without water), and a single dose of the Reference formulation (with water) in the other study period.
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole
- Keywords
- Aripiprazole, Oral Soluble Film, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify® 10 mg tablet
Healthy volunteers will receive Aripiprazole Oral Soluble Fim(OSF) 10mg orally a single of dose within 28 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Healthy volunteers will receive Aripiprazole Oral Soluble Film(OSF) 10mg orally a single of dose within 28 days with water. Receives: Drug: Aripiprazole |
| Group B | Experimental | Healthy volunteers will receive Aripiprazole Oral Soluble Film(OSF) 10mg orally a single of dose within 28 days without water. Receives: Drug: Aripiprazole |
| Gruop C | Experimental | Healthy volunteers will receive the reference drug Abilify tab. 10mg orally a single of dose within 28 days with water. Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate extent of absorption of aripiprazole OSF 10mg versus Abilify ® 10mg tablet
Measured: Baseline to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMG Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byung Jo Kim, M.D., Study director, Development Div.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501109
- Sponsor's protocol ID
- CMG-ARI-140052
- Status last verified
- Mar 2016
- First submitted
- 4 Jun 2015
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Randomized, Three-period, Crossover Comparative Bioavailability Study of a Novel Formulation of Aripiprazole 10 mg Oral Soluble Film vs the Marketed Formulation Abilify® 10 mg Tablet in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02501109
- Acronym / sponsor ID
- CMG-ARI-140052
- Conditions
- Schizophrenia
- Keywords
- Aripiprazole, Oral Soluble Film, Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- CMG Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Jul 2015 (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.
The purpose of this study is to compare the rate and extent of absorption of Aripiprazole Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male volunteers
Detailed description
The proposed study is a single centre, bioavailability, open-label, randomized, single-dose, 3-period, 6-sequence, crossover study under fasting conditions. Each volunteer will be given a single dose of the Test formulation in two study periods (with and without water), and a single dose of the Reference formulation (with water) in the other study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: AripiprazoleHealthy volunteers will receive Aripiprazole Oral Soluble Film(OSF) 10mg orally a single of dose within 28 days with water. |
| Group B | Experimental | Drug: AripiprazoleHealthy volunteers will receive Aripiprazole Oral Soluble Film(OSF) 10mg orally a single of dose within 28 days without water. |
| Gruop C | Experimental | Drug: AripiprazoleHealthy volunteers will receive the reference drug Abilify tab. 10mg orally a single of dose within 28 days with water. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, moderate smoker (no more than 9 cigarettes daily) or non-smoker, ≥45 and ≤65 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight 50.0 kg for males and 45.0 kg for females.
- Healthy as defined by:
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 42 days after the last study drug administration:
- Capable of consent.
Key exclusion criteria (19 listed)
- 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.
- Positive urine drug screen at screening.
- History of allergic reactions to aripiprazole, dimenhydrinate, benztropine, diphenhydramine or other related drugs.
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration.
- Positive pregnancy test at screening.
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 |
|---|---|---|
| AripiprazoleAlso: Abilify® 10 mg tabletHealthy volunteers will receive Aripiprazole Oral Soluble Fim(OSF) 10mg orally a single of dose within 28 days | Drug | Group A, Group B, Gruop C |
Primary outcome
The rate extent of absorption of aripiprazole OSF 10mg versus Abilify ® 10mg tablet
Time frame: Baseline to 28 days
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 24 Mar 2016.
- Individual participant dataSharing planned: Yes
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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.
Byung Jo Kim, M.D. study director
Development Div.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aripiprazole in people with Schizophrenia, run by CMG Pharmaceutical Co. Ltd.
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 19 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 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The rate extent of absorption of aripiprazole OSF 10mg versus Abilify ® 10mg tablet (time frame: Baseline to 28 days). 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 24 Mar 2016.