HealthyPhase 1NCT03151720
A Study to Assess the Relative Bioavailability of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared to Clarityne Tablets
A Phase 1 study testing loratadine (Xisimin [Test Treatment]) and loratadine (Clarityne [Reference Treatment]) in people with Healthy, run by Xian-Janssen Pharmaceutical Ltd. at 1 site in Taiwan.
Trial summary
The purpose of this study is to establish the relative bioavailability of Xisimin (loratadine) compared to Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- loratadine (Xisimin [Test Treatment]) and loratadine (Clarityne [Reference Treatment])
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2017to 8 Jul 2017
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI, weight [kilogram]/height^2 [meter^2]) between 19.0 and 26.0 kg/m2 (kilogram per meter square) (inclusive); body weight of male participants not less than 50 kilogram (kg) and body weight of female participants not less than 45 kg
- If a woman, must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry, throughout the study, and for 1 month after the last dose of study drug
- If a woman, must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period
- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 2 months after receiving the last dose of study drug
- If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Must agree to continue using an appropriate method of birth control during the study and for 3 month after the last dose of study drug
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), gastrointestinal disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or on Day -1 of each treatment period as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening or on Day -1 of each treatment period as deemed appropriate by the investigator
- Clinically significant abnormal chest radiography at screening as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for oral contraceptives and paracetamol within 14 days before the first dose of the study drug is scheduled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Randomized, Open-Label, Two-Treatment, Four-Period, Crossover Study to Assess the Relative Bioavailability of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Subjects Compared to Clarityne Tablets
The purpose of this study is to establish the relative bioavailability of Xisimin (loratadine) compared to Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2.
- Conditions
- Healthy
- Being tested
- loratadine (Xisimin [Test Treatment]), loratadine (Clarityne [Reference Treatment])
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loratadine (Xisimin [Test Treatment])Drug
Also called JNJ-1754415-AAA
Participants will receive 10 mg loratadine as Xisimin (test treatment) as per the treatment sequence.
loratadine (Clarityne [Reference Treatment])Drug
Participants will receive 10 mg loratadine as Clarityne (reference treatment) as per the treatment sequence.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Sequence 1 (ABAB) | Experimental | Participants will receive 10 milligram (mg) loratadine (1*10 mg oral tablet) as Xisimin (Treatment A) on Day 1 of Period 1 and Period 3 and 10 mg loratadine (1*10 mg oral tablet) administered as Clarityne (Treatment B) on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration. Receives: Drug: loratadine (Xisimin [Test Treatment]); Drug: loratadine (Clarityne [Reference Treatment]) |
| Cohort 1: Sequence 2 (BABA) | Experimental | Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration. Receives: Drug: loratadine (Xisimin [Test Treatment]); Drug: loratadine (Clarityne [Reference Treatment]) |
| Cohort 2: Sequence 1 (ABAB) | Experimental | Participants will receive Treatment A on Day 1 of Period 1 and Period 3 and Treatment B on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration. Receives: Drug: loratadine (Xisimin [Test Treatment]); Drug: loratadine (Clarityne [Reference Treatment]) |
| Cohort 2: Sequence 1 (BABA) | Experimental | Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration. Receives: Drug: loratadine (Xisimin [Test Treatment]); Drug: loratadine (Clarityne [Reference Treatment]) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Bioavailability of Xisimin Compared With Clarityne
Bioavailability means the extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action. Relative bioavailability is the percentage of the administered dose that is systemically available, calculated as: (AUC [0-infinity] of test divided by AUC [0-infinity] of reference) multiplied by 100, where the reference treatment is a non-intravenous administration.
Measured: Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose
Secondary outcomes (4)
Maximum Observed Plasma Concentration (Cmax) of Loratadine
The Cmax is the maximum observed plasma concentration.
Measured: Cohort 1 and Cohort 2: Predose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) for Loratadine
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Measured: Cohort 1 and Cohort 2: Predose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose
Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for Loratadine
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Cohort 1 and Cohort 2: Predose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: From Screening to Day 5 of Period 4 (Approximately 54 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Jun 2017
- Primary completion8 Jul 2017
- Study completion8 Jul 2017
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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Study director, Xian-Janssen Pharmaceutical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151720
- Sponsor's protocol ID
- CR108321
- Other IDs
- 1754415ALY1001
- Status last verified
- Aug 2017
- First submitted
- 28 Apr 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Open-Label, Two-Treatment, Four-Period, Crossover Study to Assess the Relative Bioavailability of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Subjects Compared to Clarityne Tablets
- ClinicalTrials.gov ID
- NCT03151720
- Acronym / sponsor ID
- CR108321
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 8 Jul 2017 (actual)
- Study completion
- 8 Jul 2017 (actual)
- First posted
- 12 May 2017 (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.
The purpose of this study is to establish the relative bioavailability of Xisimin (loratadine) compared to Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Sequence 1 (ABAB) | Experimental | Drug: loratadine (Xisimin [Test Treatment]), Drug: loratadine (Clarityne [Reference Treatment])Participants will receive 10 milligram (mg) loratadine (1*10 mg oral tablet) as Xisimin (Treatment A) on Day 1 of Period 1 and Period 3 and 10 mg loratadine (1*10 mg oral tablet) administered as Clarityne (Treatment B) on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration. |
| Cohort 1: Sequence 2 (BABA) | Experimental | Drug: loratadine (Xisimin [Test Treatment]), Drug: loratadine (Clarityne [Reference Treatment])Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration. |
| Cohort 2: Sequence 1 (ABAB) | Experimental | Drug: loratadine (Xisimin [Test Treatment]), Drug: loratadine (Clarityne [Reference Treatment])Participants will receive Treatment A on Day 1 of Period 1 and Period 3 and Treatment B on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration. |
| Cohort 2: Sequence 1 (BABA) | Experimental | Drug: loratadine (Xisimin [Test Treatment]), Drug: loratadine (Clarityne [Reference Treatment])Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI, weight [kilogram]/height^2 [meter^2]) between 19.0 and 26.0 kg/m2 (kilogram per meter square) (inclusive); body weight of male participants not less than 50 kilogram (kg) and body weight of female participants not less than 45 kg
- If a woman, must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry, throughout the study, and for 1 month after the last dose of study drug
- If a woman, must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period
- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 2 months after receiving the last dose of study drug
- If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Must agree to continue using an appropriate method of birth control during the study and for 3 month after the last dose of study drug
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), gastrointestinal disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or on Day -1 of each treatment period as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening or on Day -1 of each treatment period as deemed appropriate by the investigator
- Clinically significant abnormal chest radiography at screening as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for oral contraceptives and paracetamol within 14 days before the first dose of the study drug is scheduled
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 |
|---|---|---|
| loratadine (Xisimin [Test Treatment])Also: JNJ-1754415-AAAParticipants will receive 10 mg loratadine as Xisimin (test treatment) as per the treatment sequence. | Drug | Cohort 1: Sequence 1 (ABAB), Cohort 1: Sequence 2 (BABA), Cohort 2: Sequence 1 (ABAB), Cohort 2: Sequence 1 (BABA) |
| loratadine (Clarityne [Reference Treatment])Participants will receive 10 mg loratadine as Clarityne (reference treatment) as per the treatment sequence. | Drug | Cohort 1: Sequence 1 (ABAB), Cohort 1: Sequence 2 (BABA), Cohort 2: Sequence 1 (ABAB), Cohort 2: Sequence 1 (BABA) |
Primary outcome
Relative Bioavailability of Xisimin Compared With Clarityne
Time frame: Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose
Bioavailability means the extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action. Relative bioavailability is the percentage of the administered dose that is systemically available, calculated as: (AUC [0-infinity] of test divided by AUC [0-infinity] of reference) multiplied by 100, where the reference treatment is a non-intravenous administration.
4 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of Loratadine
Time frame: Cohort 1 and Cohort 2: Predose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) for Loratadine
Time frame: Cohort 1 and Cohort 2: Predose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose
Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for Loratadine
Time frame: Cohort 1 and Cohort 2: Predose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
Time frame: From Screening to Day 5 of Period 4 (Approximately 54 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 31 Aug 2017.
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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.
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial study director
Xian-Janssen Pharmaceutical Ltd.
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 loratadine (Xisimin [Test Treatment]) and loratadine (Clarityne [Reference Treatment]) in people with Healthy, run by Xian-Janssen Pharmaceutical Ltd. at 1 site in Taiwan.
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 5 inclusion and 5 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 31 Aug 2017. 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 Taiwan. 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?
Relative Bioavailability of Xisimin Compared With Clarityne (time frame: Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose). 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 31 Aug 2017.