SchizophreniaPhase 2/3NCT02072954
Bioequivalence Fasting Study in Patients
A Phase 2/3 study testing Asenapine Sublingual Tablets 10 mg in people with Schizophrenia, run by Amneal Pharmaceuticals, LLC at 2 sites in India.
Trial summary
To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10 mg. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Asenapine Sublingual Tablets 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesIndia
- Study dates
- Nov 2013to Jun 2014
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of either sex with age between 18 to 65 years (both inclusive) and have been taking a stable dose of asenapine maleate sublingual tablet, EQ 10 mg base twice daily therapy for at least three months.
- Willing and able to comply with study visit schedule and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative.
- Females of childbearing (who has not completed 01 year after menopause \& have not gone through hysterectomy or bilateral tubal ligation) potential must have a negative pregnancy test (at screening, before randomization and before check-in to housing) as well as must be non-lactating at screening and must agree to use an effective contraceptive method during study.
Who cannot join
- History of allergic or adverse reactions to asenapine maleate or olanzapine as judged by investigator
- If consuming tobacco orally (spit tobacco, gutka, pan masala, pan, etc.)
- A history of severe hepatic impairment, drug induced leukopenia/ neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease
- Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson's disease
- Abnormal laboratory results
- A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)
Show all 17Show fewer
- A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of asenapine maleate
- History of multiple syncopal episodes
- History of epilepsy or risk for seizures
- Any condition/ Abnormal baseline findings that in the investigators' judgment might increase the risk to the patient (e.g. Significant orthostatic hypotension defined as a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing) or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
- A history of alcohol or drug dependence by DSM-IV criteria during the 6-month period immediately prior to study entry
- Positive tests for drug or alcohol abuse at screening or baseline
- Use of any of the following medication in the 14 days preceding enrollment: Strong CYP3A4 inhibitors, Strong CYP3A4 inducers, CYP1A2 inhibitors, Antihypertensive medication or any medication that might predispose to orthostatic hypotension, Drugs known to suppress bone marrow function, medications known to prolong the QTc interval.
- Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening.
- Blood donation/ loss exceeding 550 mL within last 90 days.
- Any expected changes in concomitant medications during the period of study
- Compliance with outpatient medication schedule not expected
Trial locations and contacts
2 sites in 1 country.
India2 sites
Shri Hatkesh Healthcare Foundation
Jūnāgadh, Gujurat, 362 001
Divyam Hospital
Surat, Gujurat, 395 001
About this study
Official title: A Multicentric, Open Label, Randomized, Balanced, Two Treatment, Three Period, Three Sequence, Crossover, Multiple Dose, Steady State Bioequivalence Study of Asenapine Sublingual Tablets, 10 mg Manufactured by AMNEAL PHARMACEUTICALS, USA With Reference Product SAPHRIS® (Asenapine) Sublingual Tablets, 10 mg Manufactured by Catalent UK Swindon Zydis Ltd., Blagrove, Swindon, Wiltshire, SN5 8RU, UK; Distributed by Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, 08889, USA in Adult Human Male & Female Patients Under Fasting Condition.
To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10 mg.
Read the detailed description
To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10 mg following a multiple-dose administration in adult human patients who are receiving a stable twice daily dose of asenapine maleate EQ 10 mg base.
To monitor the safety and tolerability of a multiple doses of asenapine sublingual tablets 10 mg in adult human patients who are receiving a stable twice daily dose of asenapine maleate EQ 10 mg base.
- Conditions
- Schizophrenia
- Being tested
- Asenapine Sublingual Tablets 10 mg
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asenapine Sublingual Tablets 10 mgDrug
White to off-white, round, uncoated,unscored, flat-faced radius edge tablet. Debossed with A on one side and 17 on the other side
Asenapine Sublingual Tablets 10 mgDrug
Round, white to off-white sublingual tablets, with "10" on one side within a circle
| Study group | Role | What they receive |
|---|---|---|
| Asenapine Sublingual Tablets | Experimental | Asenapine Sublingual Tablets, 10 mg. Twice daily for a period of 7 days Receives: Drug: Asenapine Sublingual Tablets 10 mg |
| Saphris Subligual Tablets | Active comparator | Asenapine Sublingual Tablets, 10 mg. Twice daily for 2 periods of 7 days each. Receives: Drug: Asenapine Sublingual Tablets 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-tau
The area under plasma concentration versus time curve, over the steady state dosing interval, calculated using linear trapezoidal method.
Measured: Dosing interval on day 7
Cmax
Maximum measured plasma concentration over the steady state doing interval
Measured: Dosing interval on day 7
Secondary outcomes (4)
Cmin
Minimum measured plasma concentration over the steady state dosing interval
Measured: Dosing interval on day 7
Tmax
Time the maximum measured plasma concentration over the steady state dosing interval
Measured: Dosing interval on day 7
Cavg
Average calculated plasma concentration over the steady state dosing interval
Measured: Dosing interval on day 7
Percentage Fluctuation
[Cmax - Cmin/ Cavg] x 100
Measured: Dosing interval on day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionJun 2014
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accutest Research Laboratories (I) Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- Ashutosh Jani, MD, Principal investigator, Accutest Reserach laboratories (i) Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072954
- Sponsor's protocol ID
- ARL/CT/13/003
- Other IDs
- CTRI No. CTRI/2013/11/004152
- Status last verified
- Jun 2014
- First submitted
- 25 Feb 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Open Label, Randomized, Balanced, Two Treatment, Three Period, Three Sequence, Crossover, Multiple Dose, Steady State Bioequivalence Study of Asenapine Sublingual Tablets, 10 mg Manufactured by AMNEAL PHARMACEUTICALS, USA With Reference Product SAPHRIS® (Asenapine) Sublingual Tablets, 10 mg Manufactured by Catalent UK Swindon Zydis Ltd., Blagrove, Swindon, Wiltshire, SN5 8RU, UK; Distributed by Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, 08889, USA in Adult Human Male & Female Patients Under Fasting Condition.
- ClinicalTrials.gov ID
- NCT02072954
- Acronym / sponsor ID
- ARL/CT/13/003
- Conditions
- Schizophrenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Amneal Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Accutest Research Laboratories (I) Pvt. Ltd.
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Feb 2014 (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.
To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10 mg.
Detailed description
To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10 mg following a multiple-dose administration in adult human patients who are receiving a stable twice daily dose of asenapine maleate EQ 10 mg base.
To monitor the safety and tolerability of a multiple doses of asenapine sublingual tablets 10 mg in adult human patients who are receiving a stable twice daily dose of asenapine maleate EQ 10 mg base.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asenapine Sublingual Tablets | Experimental | Drug: Asenapine Sublingual Tablets 10 mgAsenapine Sublingual Tablets, 10 mg. Twice daily for a period of 7 days |
| Saphris Subligual Tablets | Active comparator | Drug: Asenapine Sublingual Tablets 10 mgAsenapine Sublingual Tablets, 10 mg. Twice daily for 2 periods of 7 days each. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients of either sex with age between 18 to 65 years (both inclusive) and have been taking a stable dose of asenapine maleate sublingual tablet, EQ 10 mg base twice daily therapy for at least three months.
- Willing and able to comply with study visit schedule and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative.
- Females of childbearing (who has not completed 01 year after menopause \& have not gone through hysterectomy or bilateral tubal ligation) potential must have a negative pregnancy test (at screening, before randomization and before check-in to housing) as well as must be non-lactating at screening and must agree to use an effective contraceptive method during study.
Key exclusion criteria (17 listed)
- History of allergic or adverse reactions to asenapine maleate or olanzapine as judged by investigator
- If consuming tobacco orally (spit tobacco, gutka, pan masala, pan, etc.)
- A history of severe hepatic impairment, drug induced leukopenia/ neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease
- Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson's disease
- Abnormal laboratory results
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 |
|---|---|---|
| Asenapine Sublingual Tablets 10 mgWhite to off-white, round, uncoated,unscored, flat-faced radius edge tablet. Debossed with A on one side and 17 on the other side | Drug | Asenapine Sublingual Tablets |
| Asenapine Sublingual Tablets 10 mgRound, white to off-white sublingual tablets, with "10" on one side within a circle | Drug | Saphris Subligual Tablets |
Primary outcome
AUC 0-tau
Time frame: Dosing interval on day 7
The area under plasma concentration versus time curve, over the steady state dosing interval, calculated using linear trapezoidal method.
Cmax
Time frame: Dosing interval on day 7
Maximum measured plasma concentration over the steady state doing interval
4 secondary outcomes
Cmin
Time frame: Dosing interval on day 7
Tmax
Time frame: Dosing interval on day 7
Cavg
Time frame: Dosing interval on day 7
Percentage Fluctuation
Time frame: Dosing interval on day 7
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 27 Jun 2014.
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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.
Ashutosh Jani, MD principal investigator
Accutest Reserach laboratories (i) Pvt. Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Asenapine Sublingual Tablets 10 mg in people with Schizophrenia, run by Amneal Pharmaceuticals, LLC at 2 sites in India.
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 3 inclusion and 17 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
AUC 0-tau (time frame: Dosing interval on day 7). The study lists 2 primary outcomes in all. 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 27 Jun 2014.