SchizophreniaPhase 1/2NCT03425552
A Clinical Study to Evaluate the Bioavailability Between Two Products Containing Paliperidone 100 mg in the Form of a Prolonged Release Suspension for Injection in Patients With Schizophrenia Who Are Already Stabilized in This Treatment
A Phase 1/2 study testing Paliperidone in people with Schizophrenia, run by Pharmathen S.A. at 3 sites in Jordan.
Trial summary
This clinical study will compare the equivalence of two products containing Paliperidone 100 mg in the form of a prolonged release suspension for injection in patients affected by schizophrenia who are already receiving this treatment. Each patient will receive both products (Test and Reference). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesJordan
- Study dates
- 11 Mar 2018to 2 May 2019
- Phase
- Phase 1/2
- 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
- The patient is suffering from Schizophrenia.
- The patient age is > 18 years and < 65 years old (inclusive).
- The patient has a body weight not less than 50 Kg and according to the BMI range (18.5 - 35 Kg/m2), (inclusive)
- The patient has received at least 3 doses of Paliperidone 100 mg Prolonged Release Suspension for Injection within the last 3 months.
- The patient is under fasting conditions (food and drinks) for at least 8 hours on the day of screening.
- The patient is available to volunteer for the entire study duration and is willing to adhere to all protocol requirements.
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- The findings of the patient are within the range of clinical acceptability in medical history, physical examination, vital signs, ECG, and laboratory results.
- The legally acceptable representative signed the informed consent form and the patient is able to communicate with the investigator and comprehend study-related procedures.
- The patient agrees to use a condom if he is engaged in sexual activity with a woman of childbearing potential.
- A condom is required along with another medically acceptable contraceptive method. Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide).
- Female patients may be included but must comply with the following in order to be included:
- Women having the potential to become pregnant can be enrolled only if willing to use a clinically acceptable (i.e. intrauterine device or hormonal contraceptives for at least three months) or a double barrier contraceptive measure (i.e. condom and spermicidal gel or diaphragm and spermicidal gel for at least 14 days) prior to the start of the study and through the study and for 30 days after completion of the study, or
- Surgically sterilized for at least 6 months or
- Menopausal women, for at least 1 year
Who cannot join
- The patient is pregnant or nursing (lactating) women, where pregnancy is defined as the state of the female after conception and until the termination of gestation, confirmed by a positive urine or serum pregnancy test.
- The patient has any significant or organ abnormality as determined by the principal investigator/sub-investigator.
- The patient has skin abnormalities/irritations at the potential injection site (right or left deltoid) as determined by the Principal Investigator/clinical Sub-Investigator.
- The patient has a medical or surgical condition that might interfere with the absorption, metabolism, or excretion of paliperidone.
- The patient has known allergy to the Paliperidone Palmitate or to any ingredient in the preparation.
- The patient has a history of hypersensitivity to heparin.
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- The patient intended to significantly change the smoking habits during the trial (i.e. planned cessation or start of smoking career).
- The patient will consume alcohol or caffeine or related xanthine containing foods or beverages for 48 hours prior to each dosing.
- The patient will consume grapefruit or pomelo-containing beverages and foods within 7 days prior to each dosing.
- The patient has a history of or current compulsive abuse of alcohol (more than 10 drinks weekly) or regular exposure to other substance of abuse.
- The patient is on a special diet (for example the patient is a vegetarian), or dieting (on a weight lowering plan) during the month before the study.
- The patient participated in a comparative bioavailability/ bioequivalence study within the last 90 days before first dose of period I.
- The patient participated in a clinical study within the last 90 days before first dose of period I.
- The patient donated blood or any of its constituents (1 unit or 350 ml) within the last 90 days before first dose of period I.
- The patient has positive testing for HIV I \& II and/or Hepatitis B and/or Hepatitis C using ELISA method.
- The patient has positive test for illicit drugs or alcohol before any dose.
- The patient is suffering from severe hepatic impairment.
- The patient is suffering from renal impairment
- Presence or history of clinically significant cardiovascular disease (especially known history of QT prolongation, congenital long QT syndrome, recent acute myocardial infarction, cardiac arrhythmias, or with uncompensated heart failure).
- The patient is receiving medicinal products known to prolong the QT interval, e.g. class 1 Antiarrhythmics (e.g., quinidine, disopyramide, procainamide) and class III antiarrhythmics (e.g. amiodarone, sotalol), antihistamines, antipsychotics known to prolong QT interval, and antimalarials (e.g. mefloquine, quinine), tricyclic antidepressants (eg amitriptyline), tetracyclic antidepressants (eg maprotiline).
- The patient is receiving centrally acting medicinal products e.g. anxiolytics, risperidone, opiates, etc. or alcohol
- The patient is receiving drugs that induce orthostatic hypotension (e,g other antipsychotics, tricyclic).
- The patient is receiving medicinal products known to lower the seizure threshold (e.g. phenothiazines or butyrophenones, tricyclics or SSRIs, tramadol, mefloquine, etc.)
- The patient is receiving carbamazepine (causes decrease in mean steady state Cmax and AUC of Paliperidone)
- The patient has current thoughts of suicide or violent tendencies at screening.
Trial locations and contacts
3 sites in 1 country.
Jordan3 sites
Al-Esraa Hospital
Amman
King Abdullah University Hospital
Ar Ramtha
Princes Basma Teaching Hospital
Irbid
About this study
Official title: Α Randomized, Two-way, Two-treatment, Two-period, Crossover, Open Label, Laboratory-blind, Comparative Bioavailability Study at Steady State Between Paliperidone 100 mg Prolonged Release Suspension for Injection (Test Product) and Xeplion® 100 mg Prolonged Release Suspension for Injection (Reference Product) Following Multiple Intramuscular Injections (Five Doses in Each Period, One Dose Every 28 Days) Administration to Patients With Schizophrenia Who Are Already Receiving a Stable Regimen of Paliperidone Prolonged Release Suspension Via The Intramuscular Route
This clinical study will compare the equivalence of two products containing Paliperidone 100 mg in the form of a prolonged release suspension for injection in patients affected by schizophrenia who are already receiving this treatment. Each patient will receive both products (Test and Reference). In total, each patient will receive 10 doses (five doses of the Test product and five doses of the Reference product; one dose every 28 days). Furthermore, the two products (Test and Reference) will be compared with regard to their safety and tolerability.
Read the detailed description
This study will be a randomized, two-way, two-treatment, two-period, crossover, open label, laboratory-blind, multiple dose study at steady state, under fasting conditions.
To main purpose of this study is to determine the relative bioavailability of Paliperidone 100 mg prolonged release suspension for injection (Pharmathen S.A, Greece) and Xeplion® (Paliperidone) 100 mg Prolonged Release Suspension for Injection (Janssen Pharmaceutica N.V., Belgium) following multiple Intramuscular Injections (five doses in each period, one dose every 28 days) administration to patients with schizophrenia who are already receiving a stable regimen of paliperidone prolonged release suspension via the intramuscular route.
The secondary objective of this study is to evaluate the safety and tolerability between the two products.
Five injections of Paliperidone 100 mg prolonged release suspension will be administered intramuscularly (in the deltoid muscle) to study patients in each period (one injection every 28 days).
A total of 70 patients will be randomized into two sequences (Test-Reference or Reference-Test).
The doses will be administered to study patients in each period, according to the randomization plan , as clarified in the table below:
Period I Day 0 First dose Day 28 Second dose Day 56 Third dose Day 84 Fourth dose Day 112 Fifth Dose
Period II Day 140 First dose Day 168 Second dose Day 196 Third dose Day 224 Fourth dose Day 252 Fifth Dose
Following up the last dose of each period, a series of blood samples will be collected from each patient in order to determine the bioavailability of the received drug. More specifically, patients will return to the clinical site to give the scheduled PK blood samples on Day 113, Day114, Day 115, Day 116, Day 117, Day 118, Day 119, Day 120, Day 121, Day 122, Day 123, Day 124, Day 125, Day 126, Day 127, Day 128, Day 129, Day 130, Day 132, Day 134, Day 136, Day 138, Day 253, Day 254, Day 255, Day 256, Day 257, Day 258, Day 259, Day 260, Day 261, Day 262, Day 263, Day 264, Day 265, Day 266, Day 267, Day 268, Day 269, Day 270, Day 272, Day 274, Day 276, Day 278 and Day 280.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaliperidoneDrug
Paliperidone Palmitate extended-release injectable suspension 156 mg (100 mg of Paliperidone)
PaliperidoneDrug
Also called Xeplion
Paliperidone Palmitate 156 mg (equivalent to Paliperiodne 100 mg) extended release injectable suspension
| Study group | Role | What they receive |
|---|---|---|
| Test treatment | Experimental | Paliperidone palmitate extended-release injectable suspension for intramuscular use 156 mg (100 mg of Paliperiodne) Receives: Drug: Paliperidone |
| Reference treatment | Active comparator | Paliperidone palmitate 156 mg (equivalent to Paliperidone 100 mg) extended release injectable suspension Receives: Drug: Paliperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax(ss)
Maximum plasma concentration at steady state
Measured: 28 days
AUC0-τ(ss)
AUC during a dosage interval at steady state
Measured: 28 days
Cτ(ss)
Concentration at the end of the dosing interval at steady state
Measured: 28 days
Secondary outcomes (4)
Cmin(ss)
Minimum plasma concentration at steady state
Measured: 28 days
Fluctuation
(Cmax,ss - Cmin,ss) / Cavg,ss
Measured: 28 days
Tmax(ss)
Time until Cmax(ss) is reached
Measured: 28 days
Number of participants with treatment-related adverse events
Measured: 281 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start11 Mar 2018
- Primary completion2 May 2019
- Study completion2 May 2019
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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmathen S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lina Sabbah, Study director, Triumpharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425552
- Sponsor's protocol ID
- PAL.100/316
- Status last verified
- Oct 2018
- First submitted
- 26 Jan 2018
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Α Randomized, Two-way, Two-treatment, Two-period, Crossover, Open Label, Laboratory-blind, Comparative Bioavailability Study at Steady State Between Paliperidone 100 mg Prolonged Release Suspension for Injection (Test Product) and Xeplion® 100 mg Prolonged Release Suspension for Injection (Reference Product) Following Multiple Intramuscular Injections (Five Doses in Each Period, One Dose Every 28 Days) Administration to Patients With Schizophrenia Who Are Already Receiving a Stable Regimen of Paliperidone Prolonged Release Suspension Via The Intramuscular Route
- ClinicalTrials.gov ID
- NCT03425552
- Acronym / sponsor ID
- PAL.100/316
- Conditions
- Schizophrenia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pharmathen S.A.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2018 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 7 Feb 2018 (actual)
- 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 clinical study will compare the equivalence of two products containing Paliperidone 100 mg in the form of a prolonged release suspension for injection in patients affected by schizophrenia who are already receiving this treatment. Each patient will receive both products (Test and Reference). In total, each patient will receive 10 doses (five doses of the Test product and five doses of the Reference product; one dose every 28 days). Furthermore, the two products (Test and Reference) will be compared with regard to their safety and tolerability.
Detailed description
This study will be a randomized, two-way, two-treatment, two-period, crossover, open label, laboratory-blind, multiple dose study at steady state, under fasting conditions.
To main purpose of this study is to determine the relative bioavailability of Paliperidone 100 mg prolonged release suspension for injection (Pharmathen S.A, Greece) and Xeplion® (Paliperidone) 100 mg Prolonged Release Suspension for Injection (Janssen Pharmaceutica N.V., Belgium) following multiple Intramuscular Injections (five doses in each period, one dose every 28 days) administration to patients with schizophrenia who are already receiving a stable regimen of paliperidone prolonged release suspension via the intramuscular route.
The secondary objective of this study is to evaluate the safety and tolerability between the two products.
Five injections of Paliperidone 100 mg prolonged release suspension will be administered intramuscularly (in the deltoid muscle) to study patients in each period (one injection every 28 days).
A total of 70 patients will be randomized into two sequences (Test-Reference or Reference-Test).
The doses will be administered to study patients in each period, according to the randomization plan , as clarified in the table below:
Period I Day 0 First dose Day 28 Second dose Day 56 Third dose Day 84 Fourth dose Day 112 Fifth Dose
Period II Day 140 First dose Day 168 Second dose Day 196 Third dose Day 224 Fourth dose Day 252 Fifth Dose
Following up the last dose of each period, a series of blood samples will be collected from each patient in order to determine the bioavailability of the received drug. More specifically, patients will return to the clinical site to give the scheduled PK blood samples on Day 113, Day114, Day 115, Day 116, Day 117, Day 118, Day 119, Day 120, Day 121, Day 122, Day 123, Day 124, Day 125, Day 126, Day 127, Day 128, Day 129, Day 130, Day 132, Day 134, Day 136, Day 138, Day 253, Day 254, Day 255, Day 256, Day 257, Day 258, Day 259, Day 260, Day 261, Day 262, Day 263, Day 264, Day 265, Day 266, Day 267, Day 268, Day 269, Day 270, Day 272, Day 274, Day 276, Day 278 and Day 280.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test treatment | Experimental | Drug: PaliperidonePaliperidone palmitate extended-release injectable suspension for intramuscular use 156 mg (100 mg of Paliperiodne) |
| Reference treatment | Active comparator | Drug: PaliperidonePaliperidone palmitate 156 mg (equivalent to Paliperidone 100 mg) extended release injectable suspension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The patient is suffering from Schizophrenia.
- The patient age is > 18 years and < 65 years old (inclusive).
- The patient has a body weight not less than 50 Kg and according to the BMI range (18.5 - 35 Kg/m2), (inclusive)
- The patient has received at least 3 doses of Paliperidone 100 mg Prolonged Release Suspension for Injection within the last 3 months.
- The patient is under fasting conditions (food and drinks) for at least 8 hours on the day of screening.
Key exclusion criteria (25 listed)
- The patient is pregnant or nursing (lactating) women, where pregnancy is defined as the state of the female after conception and until the termination of gestation, confirmed by a positive urine or serum pregnancy test.
- The patient has any significant or organ abnormality as determined by the principal investigator/sub-investigator.
- The patient has skin abnormalities/irritations at the potential injection site (right or left deltoid) as determined by the Principal Investigator/clinical Sub-Investigator.
- The patient has a medical or surgical condition that might interfere with the absorption, metabolism, or excretion of paliperidone.
- The patient has known allergy to the Paliperidone Palmitate or to any ingredient in the preparation.
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 |
|---|---|---|
| PaliperidonePaliperidone Palmitate extended-release injectable suspension 156 mg (100 mg of Paliperidone) | Drug | Test treatment |
| PaliperidoneAlso: XeplionPaliperidone Palmitate 156 mg (equivalent to Paliperiodne 100 mg) extended release injectable suspension | Drug | Reference treatment |
Primary outcome
Cmax(ss)
Time frame: 28 days
Maximum plasma concentration at steady state
AUC0-τ(ss)
Time frame: 28 days
AUC during a dosage interval at steady state
Cτ(ss)
Time frame: 28 days
Concentration at the end of the dosing interval at steady state
4 secondary outcomes
Cmin(ss)
Time frame: 28 days
Fluctuation
Time frame: 28 days
Tmax(ss)
Time frame: 28 days
Number of participants with treatment-related adverse events
Time frame: 281 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 19 Jul 2019.
- Guideline for Good Clinical Practice E6(R2)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lina Sabbah study director
Triumpharma
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paliperidone in people with Schizophrenia, run by Pharmathen S.A. at 3 sites in Jordan.
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 14 inclusion and 25 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Jordan. 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 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Cmax(ss) (time frame: 28 days). The study lists 3 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 19 Jul 2019.