Psoriasis and Psoriatic ArthritisPhase 3NCT06084663
Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects
A Phase 3 study testing Apremilast 30 mg Tablets and Otezla 30 mg film-coated tablets in people with Psoriasis and Psoriatic Arthritis, run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial summary
An open label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover, bioequivalence study in normal, healthy, adult, human subjects under fasting condition Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis and Psoriatic Arthritis
- What is being tested?
- Apremilast 30 mg Tablets and Otezla 30 mg film-coated tablets
- 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 siteIndia
- Study dates
- 15 Feb 2023to 25 Apr 2023
- Phase
- Phase 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker, Normal, healthy, adult, human, subjects between 18 and 45 years of age (both inclusive).
- Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kg/height in m2.
- Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings (P/A view).
- Able to understand and comply with the study procedures, in the opinion of the investigator.
- Able to give voluntary written informed consent for participation in the trial.
- In case of female subjects:
- Surgically sterilized at least 6 months prior to study participation. Or If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- And Serum pregnancy test must be negative.
Who cannot join
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion or Use of medication [non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines)] at any time from 14 days prior to dosing of period-I and Use of any prescribed systemic or topical medication from 30 days prior to dosing of period-I and any vaccine (including COVID-19 vaccine) within 14 days prior to dosing of period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- Consumption of grapefruits or its products within a period of 72 hours prior to dosing of period-I.
- Smokers or who have smoked within last 06 months prior to start of the study.
- A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing of period-I.
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- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
- History or presence of seizure or psychiatric disorder
- A history of difficulty with donating blood.
- Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication**.
- ** If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
- Difficulty in swallowing tablet or oral solid dosage form
- A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- A positive test result for HIV antibody (1 \&/or 2).
- An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to receiving the study drug in period I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Any condition which places the subject at unacceptable risk if he/she were to participate in the study, or confounds the ability to interpret data from the study.
- Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure, colon resection, irritable bowel syndrome, Crohn's disease, etc.
- The QTc interval more than 450 msec for male subjects and 460 msec for female subjects at the time of screening.
- Nursing mothers (for female subjects).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Cross Over Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
An open label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover, bioequivalence study in normal, healthy, adult, human subjects under fasting condition
- Conditions
- Psoriasis and Psoriatic Arthritis
- Being tested
- Apremilast 30 mg Tablets, Otezla 30 mg film-coated tablets
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apremilast 30 mg TabletsDrug
Each film-coated tablet contains 30 mg of apremilast
Otezla 30 mg film-coated tabletsDrug
Each film-coated tablet contains 30 mg of apremilast
| Study group | Role | What they receive |
|---|---|---|
| Apremilast 30 mg Tablets | Experimental | One tablet was administered orally to each subject as per randomization schedule in each period Receives: Drug: Apremilast 30 mg Tablets; Drug: Otezla 30 mg film-coated tablets |
| Otezla 30 mg film-coated tablets | Active comparator | One tablet was administered orally to each subject as per randomization schedule in each period Receives: Drug: Apremilast 30 mg Tablets; Drug: Otezla 30 mg film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration
Measured: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000 and 48.000 hours
AUC0-t
Area under the plasma concentration curve from administration to last observed concentration at time t
Measured: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000 and 48.000 hours
Secondary outcomes (1)
AUC0-∞
Area under the plasma concentration curve extrapolated to infinite time
Measured: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000 and 48.000 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start15 Feb 2023
- Primary completion25 Feb 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis and Psoriatic ArthritisStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hakan Gürpınar, Study director, Humanis Saglık
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084663
- Sponsor's protocol ID
- 0005-22
- Status last verified
- Dec 2023
- First submitted
- 10 Oct 2023
- Last updated
- 13 Dec 2023
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Cross Over Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT06084663
- Acronym / sponsor ID
- 0005-22
- Conditions
- Psoriasis and Psoriatic Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 16 Oct 2023 (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.
An open label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover, bioequivalence study in normal, healthy, adult, human subjects under fasting condition
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apremilast 30 mg Tablets | Experimental | Drug: Apremilast 30 mg Tablets, Drug: Otezla 30 mg film-coated tabletsOne tablet was administered orally to each subject as per randomization schedule in each period |
| Otezla 30 mg film-coated tablets | Active comparator | Drug: Apremilast 30 mg Tablets, Drug: Otezla 30 mg film-coated tabletsOne tablet was administered orally to each subject as per randomization schedule in each period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Non-smoker, Normal, healthy, adult, human, subjects between 18 and 45 years of age (both inclusive).
- Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kg/height in m2.
- Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings (P/A view).
- Able to understand and comply with the study procedures, in the opinion of the investigator.
- Able to give voluntary written informed consent for participation in the trial.
Key exclusion criteria (22 listed)
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion or Use of medication [non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines)] at any time from 14 days prior to dosing of period-I and Use of any prescribed systemic or topical medication from 30 days prior to dosing of period-I and any vaccine (including COVID-19 vaccine) within 14 days prior to dosing of period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- Consumption of grapefruits or its products within a period of 72 hours prior to dosing of period-I.
- Smokers or who have smoked within last 06 months prior to start of the study.
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 |
|---|---|---|
| Apremilast 30 mg TabletsEach film-coated tablet contains 30 mg of apremilast | Drug | Apremilast 30 mg Tablets, Otezla 30 mg film-coated tablets |
| Otezla 30 mg film-coated tabletsEach film-coated tablet contains 30 mg of apremilast | Drug | Apremilast 30 mg Tablets, Otezla 30 mg film-coated tablets |
Primary outcome
Cmax
Time frame: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000 and 48.000 hours
Maximum plasma concentration
AUC0-t
Time frame: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000 and 48.000 hours
Area under the plasma concentration curve from administration to last observed concentration at time t
1 secondary outcome
AUC0-∞
Time frame: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000 and 48.000 hours
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 13 Dec 2023.
- 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.
Hakan Gürpınar study director
Humanis Saglık
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apremilast 30 mg Tablets and Otezla 30 mg film-coated tablets in people with Psoriasis and Psoriatic Arthritis, run by Humanis Saglık Anonim Sirketi at 1 site 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 8 inclusion and 22 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 13 Dec 2023. 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 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 phase mean?
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?
Cmax (time frame: The venous blood samples will be withdrawn at pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 10.000, 12.000, 24.000, 36.000 and 48.000 hours). 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 13 Dec 2023.