HealthyPhase 1NCT05356143
A Comparative Study of Rupatadine 10 mg Tablets and Clarinex® 5 mg Tablets Under Fasting Conditions
A Phase 1 study testing Rupatadine in people with Healthy, run by J. Uriach and Company at 1 site in Canada.
Trial summary
This is an open-label, single-dose, randomized, three-period, two-treatment, threesequence, crossover, PK, partial replicate, and comparative bioavailability study. This study may be conducted in groups. The same protocol requirements and procedures will be followed for each group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rupatadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 2 Dec 2021to 5 Jan 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-smoking, male and female subjects, 18 years of age or older.
- BMI ≥19 kg/m2.
- Females may be of childbearing or non-childbearing potential:
- Childbearing potential:
- o Physically capable of becoming pregnant
- Non-childbearing potential:
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- Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or
- Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause).
- QTc ≤450 msec [corrected using Bazett's formula (QTcB)].
- Willing to use acceptable, effective methods of contraception for the duration of the entire study.
- Able to tolerate venipuncture.
- Be informed of the nature of the study and give written consent prior to any study procedure.
Who cannot join
- Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Known or suspected carcinoma.
- Known history or presence of hypersensitivity or idiosyncratic reaction to rupatadine, desloratadine, or any other drug substances with similar activity.
- Known history or presence of clinically significant angioedema.
- Known history or presence of clinically significant lactose, galactose, or fructose intolerance.
- Any acute illness (e.g. cold, acute infection) which is considered significant by the Investigator and that has not resolved within 7 days before the first drug administration.
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- Presence of hepatic or renal dysfunction.
- Presence of hay fever, seasonal allergy, or rhinitis.
- Presence of sinusitis.
- Presence of nasal symptoms (e.g., blocked and/or runny nose).
- History of atopic allergy (e.g., asthma, urticaria, eczematous dermatitis).
- History of drug or alcohol addiction requiring treatment.
- Positive test result for COVID-19 Ag, HIV, Hepatitis B surface Ag, or Hepatitis C Ab.
- Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine.
- Difficulty fasting or consuming standard meals.
- Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
- Females who:
- Have used implanted, injected, intravaginal, or intrauterine hormonal contraceptives within 6 months prior to drug administration;
- Have used oral or transdermal hormonal contraceptives within 21 days prior to drug administration;
- Are pregnant (serum hCG consistent with pregnancy); or
- Are lactating.
- Donation or loss of whole blood (including clinical trials):
- ≥50 mL and <500 mL within 30 days prior to drug administration;
- ≥500 mL within 56 days prior to drug administration.
- Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
- On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).
- Have had a tattoo or body piercing within 30 days prior to drug administration.
- Have clinically significant findings in vital signs measurements.
- Have clinically significant findings in a 12-lead ECG.
- Have clinically significant abnormal laboratory values.
- Have significant diseases.
- Have clinically significant findings from a physical examination.
- Use of any of the following within 30 days prior to drug administration:
- Antihistamines;
- CYP3A4 substrates with a narrow therapeutic index (e.g., ciclosporin, tacrolimus, sirolimus, everolimus, cisapride);
- Drugs known to alter gastrointestinal pH/movement (e.g., cimetidine, omeprazole, ranitidine);
- Drugs known to prolong QTc;
- Enzyme-modifying drugs known to induce/inhibit hepatic drug metabolism, specifically CYP 2C9, 2C19, 2D6, and 3A4 (e.g., ketoconazole, itraconazole, fluconazole, posaconazole, voriconazole, clarithromycin, azithromycin, erythromycin, diltiazem, HIV protease inhibitors, nefazodone);
- Fluoxetine; or
- Statins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Partial-Replicate, Pharmacokinetic, and Comparative Bioavailability Study of Rupatadine 10 mg Tablets and Clarinex® 5 mg Tablets Under Fasting Conditions
This is an open-label, single-dose, randomized, three-period, two-treatment, threesequence, crossover, PK, partial replicate, and comparative bioavailability study. This study may be conducted in groups. The same protocol requirements and procedures will be followed for each group.
Read the detailed description
This study will allow for the determination of the PK and intra-subject variability of rupatadine and metabolites. In addition, this study will compare the bioavailability of the rupatadine formulation (Drug Product 1) to a FDA-approved reference product (Clarinex®) (Drug Product 2) as far as the rupatadine metabolite desloratadine, and the derived compounds, is concerned.
Comparative bioavailability between Drug Product 1 and Drug Product 2 will be determined by a statistical comparison of the AUCt, AUCinf, and Cmax parameters for desloratadine (UR-12790), 3-OH desloratadine (UR-12788), 5-OH desloratadine (UR-12767), 6-OH desloratadine (UR-12766), and 3-OH-glucuronide-desloratadine (UR-12335).
- Conditions
- Healthy
- Being tested
- Rupatadine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RupatadineDrug
Also called Pafinur
Oral single dose 10 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | Subjects will take comparator and active drug at different study periods Treatment sequence AAB Receives: Drug: Rupatadine |
| Sequence 2 | Other | Treatment sequence ABA Receives: Drug: Rupatadine |
| Sequence 3 | Other | Treatment sequence BAA Receives: Drug: Rupatadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparation of drug products
To compare the levels of desloratadine (UR-12790) and its related metabolites (UR-2788, UR-12767, UR-12766, UR-12335) after single-dose administration of Drug Product 1 and Drug Product 2 in healthy subjects under fasting conditions
Measured: 3 weeks
Secondary outcomes (3)
Bioavailability of drug product 1
To verify the levels of the pre-desloratadine metabolites (UR-12680, UR-12338, UR- 2605, UR-12333, UR-12783) after the administration of Drug Product 1.
Measured: 1 week
Intra-subject variability
To determine the levels of rupatadine (UR-12592) and the intra-subject variability of rupatadine (UR-12592) and its' metabolites after the administration of Drug Product 1.
Measured: 1 week
Number of adverse events
By checking the adverse events ocurring during the study
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start2 Dec 2021
- Primary completion13 Jan 2022
- Study completion5 Jan 2023
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is an open-label, single-dose, randomized, three-period, two-treatment, threesequence, crossover, PK, partial replicate, and comparative bioavailability study.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- J. Uriach and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356143
- Sponsor's protocol ID
- 2020-4903 Version: 1.0
- Status last verified
- Mar 2023
- First submitted
- 26 Nov 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Partial-Replicate, Pharmacokinetic, and Comparative Bioavailability Study of Rupatadine 10 mg Tablets and Clarinex® 5 mg Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05356143
- Acronym / sponsor ID
- 2020-4903 Version: 1.0
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- J. Uriach and CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 2 May 2022 (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 is an open-label, single-dose, randomized, three-period, two-treatment, threesequence, crossover, PK, partial replicate, and comparative bioavailability study. This study may be conducted in groups. The same protocol requirements and procedures will be followed for each group.
Detailed description
This study will allow for the determination of the PK and intra-subject variability of rupatadine and metabolites. In addition, this study will compare the bioavailability of the rupatadine formulation (Drug Product 1) to a FDA-approved reference product (Clarinex®) (Drug Product 2) as far as the rupatadine metabolite desloratadine, and the derived compounds, is concerned.
Comparative bioavailability between Drug Product 1 and Drug Product 2 will be determined by a statistical comparison of the AUCt, AUCinf, and Cmax parameters for desloratadine (UR-12790), 3-OH desloratadine (UR-12788), 5-OH desloratadine (UR-12767), 6-OH desloratadine (UR-12766), and 3-OH-glucuronide-desloratadine (UR-12335).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an open-label, single-dose, randomized, three-period, two-treatment, threesequence, crossover, PK, partial replicate, and comparative bioavailability study.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Drug: RupatadineSubjects will take comparator and active drug at different study periods Treatment sequence AAB |
| Sequence 2 | Other | Drug: RupatadineTreatment sequence ABA |
| Sequence 3 | Other | Drug: RupatadineTreatment sequence BAA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy, non-smoking, male and female subjects, 18 years of age or older.
- BMI ≥19 kg/m2.
- Females may be of childbearing or non-childbearing potential:
- o Physically capable of becoming pregnant
- QTc ≤450 msec [corrected using Bazett's formula (QTcB)].
Key exclusion criteria (40 listed)
- Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Known or suspected carcinoma.
- Known history or presence of hypersensitivity or idiosyncratic reaction to rupatadine, desloratadine, or any other drug substances with similar activity.
- Known history or presence of clinically significant angioedema.
- Known history or presence of clinically significant lactose, galactose, or fructose intolerance.
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 |
|---|---|---|
| RupatadineAlso: PafinurOral single dose 10 mg tablet | Drug | Sequence 1, Sequence 2, Sequence 3 |
Primary outcome
Comparation of drug products
Time frame: 3 weeks
To compare the levels of desloratadine (UR-12790) and its related metabolites (UR-2788, UR-12767, UR-12766, UR-12335) after single-dose administration of Drug Product 1 and Drug Product 2 in healthy subjects under fasting conditions
3 secondary outcomes
Bioavailability of drug product 1
Time frame: 1 week
Intra-subject variability
Time frame: 1 week
Number of adverse events
Time frame: 1 week
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 23 Mar 2023.
- Medexus Pharmaceuticals Inc. RupallTM, Rupatadine (as rupatidine fumarate), Tablet 10 mg, Oral Solution 1 mg/mL. Canada: Health Canada; Revised June 2, 2020.Link provided by the sponsor.
- Merck Sharp \& Dohme Corp. Highlights of Prescribing Information. Clarinex® (desloratadine) Tablets, RediTabs, and Oral Solution for oral use. USA: FDA; Revised 3/2019.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.
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 Rupatadine in people with Healthy, run by J. Uriach and Company at 1 site in Canada.
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 12 inclusion and 40 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 23 Mar 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 Canada. 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?
Comparation of drug products (time frame: 3 weeks). 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 23 Mar 2023.