Histamine H1 Antagonists, Non-SedatingPhase 1BordeauxNCT02593747
To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup
A Phase 1 study testing Loratadine oral solution and Loratadine (Claritin peach syrup) in people with Histamine H1 Antagonists, Non-Sedating, run by Bayer at 1 site in Germany.
Trial summary
To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus Claritin Peach Syrup 1mg/mL (ANNA Formula) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Histamine H1 Antagonists, Non-Sedating
- What is being tested?
- Loratadine oral solution and Loratadine (Claritin peach syrup)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Mar 2016
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult (men or women), age 18 to 55 years inclusive;
- Body mass index 18.5 to 30.0 kg/m*2 inclusive;
- Able to read and understand the written informed consent for study-related information and instruction;
- Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol;
- Agree not to donate whole blood or components of blood (e.g. plasma, thrombocytes) starting from signing the informed consent form through 30 days after the last study procedure, except for the blood samples collected for this study;
- Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, injectable contraceptive (e.g. Depo-Provera), or a double barrier and have a negative pregnancy test at Screening and prior to study drug administration on Day 0 of Dosing Periods 1 and 2. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy;
Who cannot join
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal;
- Known hypersensitivity to any medication (active substances or excipients of the preparations) to be used in the study;
- Known galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Known severe allergies (e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids);
- Use of, within 1 month before the first study drug administration, systemic or topical medicines or substances which might affect the study objectives, e.g
- any drug known to induce cytochrome P3A4/5 or P Glycoprotein (e.g. rifampin, carbamazepine, St. John's wort);
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- any drug known to inhibit cytochrome P3A4/5 or P Glycoprotein (e.g. erythromycin, clarithromycin, chloramphenicol, ketoconazole);
- any drug known to induce cytochrome P2D6 (e.g. rifampin, dexamethasone);
- any drug known to inhibit cytochrome P2D6 (e.g. cimetidine, desipramine, fluoxetine, metoclopramide);
- Positive urine pregnancy, urine drug test or Hepatitis B, hepatitis C or HIV tests;
- Clinically relevant findings in the physical examination, e.g., signs of bleeding diathesis, signs of heart failure, evidence of peripheral circulatory disturbances, and skin abnormalities;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Single-center, Randomized, Open-label, Two-way Crossover Study in Healthy Adults to Assess the Bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) Versus Claritin Peach Syrup 1mg/mL (ANNA Formula)
To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus Claritin Peach Syrup 1mg/mL (ANNA Formula)
- Conditions
- Histamine H1 Antagonists, Non-Sedating
- Being tested
- Loratadine oral solution, Loratadine (Claritin peach syrup)
- Keywords
- Allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loratadine oral solutionDrug
Subjects received a single oral dose of 10 mg loratadine oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in any intervention period.
Loratadine (Claritin peach syrup)Drug
Subjects received a single oral dose of 10 mg loratadine claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in any intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Loratadine oral solution/syrup then Claritin peach syrup | Experimental | Subjects received a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments. Receives: Drug: Loratadine oral solution; Drug: Loratadine (Claritin peach syrup) |
| Claritin peach syrup then Loratadine oral solution/syrup | Experimental | Subjects received a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments. Receives: Drug: Loratadine oral solution; Drug: Loratadine (Claritin peach syrup) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: Area Under the Concentration Versus Time Curve From Zero to the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Loratadine in Plasma (AUC[0-tlast]) After Single Oral Dose of Loratadine
Area under the concentration versus time curve from zero to the last data point greater than (>) LLOQ (AUC[0-tlast]) after single dose.
Measured: 0 hour (h) (pre-dose) to 72 h post-dose
Maximum Observed Concentration (Cmax) of Loratadine in Plasma After Single Oral Dose of Loratadine
Maximum observed loratadine concentration in plasma, directly taken from analytical data.
Measured: 0 h (pre-dose) to 72 h post-dose
Secondary outcomes (15)
Time to Reach Maximum Concentration (tmax) in Plasma After Single Dose of Loratadine
Time to reach maximum loratadine concentration in plasma after its single oral dose, directly taken from analytical data.
Measured: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Loratadine in Plasma After Single Dose
Area under the concentration versus time curve from zero to infinity after single dose.
Measured: 0 h (pre-dose) to 72 h post-dose
Half-Life (t1/2) Associated With the Terminal Slope of Loratadine After Single Dose
Half-life associated with the terminal slope.
Measured: 0 h (pre-dose) to 72 h post-dose
Total Body Clearance (CL/F) of Loratadine Calculated After its Single Oral Administration
Total body clearance of loratadine calculated after extravascular application.
Measured: 0 h (pre-dose) to 72 h post-dose
Percentage of Area Under the Concentration Versus Time Curve (AUC) From the Last Calculated Data Point Greater Than Lower Limit of Quantification [LLOQ]) to Infinity (%AUC[tlast-∞]) After Single Oral Administration of Loratadine
Percentage of AUC from the last calculated data point > LLOQ to infinity was measured.
Measured: 0 h (pre-dose) to 72 h post-dose
Apparent Terminal Rate Constant (λz) of Loratadine After Single Dose
Apparent terminal rate constant, calculated from the slope of a log-linear regression of the unweighted data considering the last concentration-time points > LLOQ.
Measured: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to 72 Hours (AUC[0-72]) of Lloratadine in Plasma After Single Oral Dose
Area under the concentration versus time curve from zero to 72 h after single dose.
Measured: 0 h (pre-dose) to 72 h post-dose
Maximum Observed Concentration (Cmax) of Desloratadine in Plasma After Single Oral Dose of Loratadine
Maximum observed desloratadine concentration in plasma, directly taken from analytical data.
Measured: 0 h (pre-dose) to 72 h post-dose
Time to Reach Maximum Concentration (tmax) of Desloratadine in Plasma After Single Dose of Loratadine
Time to reach maximum drug concentration in the measured matrix, directly observed from the analytical data.
Measured: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Desoratadine in Plasma (AUC[0-tlast]) After Single Oral Dose of Loratadine
Area under the concentration versus time curve from zero to the last data point > LLOQ (AUC[0-tlast]) after single dose.
Measured: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to 72 Hours (AUC[0-72]) of Desloratadine in Plasma After Single Oral Dose of Loratadine
Area under the concentration versus time curve from zero to 72 h after single dose. AUC and residual area were not evaluated because the concentration at 72 h was quantifiable in the majority of profiles.
Measured: 0 h (pre-dose) to 72 h post-dose
Time of Last Concentration Above the Lower Limit Of Quantitation (LLOQ) of Desloratadine, Directly Taken From Analytical Data (tlast)
Time of last concentration above LLOQ, directly taken from analytical data.
Measured: 0 h (pre-dose) to 72 h post-dose
Half-Life (t1/2) Associated With the Terminal Slope of Desoratadine After Single Dose of Loratadine
Half-life associated with the terminal slope.
Measured: 0 h (pre-dose) to 72 h post-dose
Percentage of Area Under the Concentration Versus Time Curve (AUC) from the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) to Infinity (%AUC[tlast-∞]) of Desoratadine After Single Oral Administration of Loratadine
Percentage of area under the concentration versus time curve from zero to the last data point > LLOQ in plasma (AUC[(0-tlast]) was measured.
Measured: 0 h (pre-dose) to 72 h post-dose
Apparent Terminal Rate Constant (λz) of Desoratadine After Single Dose of Loratadine
Apparent terminal rate constant, calculated from the slope of a log-linear regression of the unweighted data considering the last concentration-time points > LLOQ.
Measured: 0 h (pre-dose) to 72 h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histamine H1 Antagonists, Non-SedatingStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593747
- Sponsor's protocol ID
- 18199
- Other IDs
- 2015-002720-12, 2015
- Acronym
- Bordeaux
- Status last verified
- Feb 2017
- First submitted
- 30 Oct 2015
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Single-center, Randomized, Open-label, Two-way Crossover Study in Healthy Adults to Assess the Bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) Versus Claritin Peach Syrup 1mg/mL (ANNA Formula)
- ClinicalTrials.gov ID
- NCT02593747
- Acronym / sponsor ID
- Bordeaux / 18199
- Conditions
- Histamine H1 Antagonists, Non-Sedating
- Keywords
- Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Nov 2015 (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 assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus Claritin Peach Syrup 1mg/mL (ANNA Formula)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loratadine oral solution/syrup then Claritin peach syrup | Experimental | Drug: Loratadine oral solution, Drug: Loratadine (Claritin peach syrup)Subjects received a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments. |
| Claritin peach syrup then Loratadine oral solution/syrup | Experimental | Drug: Loratadine oral solution, Drug: Loratadine (Claritin peach syrup)Subjects received a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult (men or women), age 18 to 55 years inclusive;
- Body mass index 18.5 to 30.0 kg/m*2 inclusive;
- Able to read and understand the written informed consent for study-related information and instruction;
- Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol;
- Agree not to donate whole blood or components of blood (e.g. plasma, thrombocytes) starting from signing the informed consent form through 30 days after the last study procedure, except for the blood samples collected for this study;
Key exclusion criteria (11 listed)
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal;
- Known hypersensitivity to any medication (active substances or excipients of the preparations) to be used in the study;
- Known galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Known severe allergies (e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids);
- Use of, within 1 month before the first study drug administration, systemic or topical medicines or substances which might affect the study objectives, e.g
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 oral solutionSubjects received a single oral dose of 10 mg loratadine oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in any intervention period. | Drug | Claritin peach syrup then Loratadine oral solution/syrup, Loratadine oral solution/syrup then Claritin peach syrup |
| Loratadine (Claritin peach syrup)Subjects received a single oral dose of 10 mg loratadine claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in any intervention period. | Drug | Claritin peach syrup then Loratadine oral solution/syrup, Loratadine oral solution/syrup then Claritin peach syrup |
Primary outcome
Primary: Area Under the Concentration Versus Time Curve From Zero to the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Loratadine in Plasma (AUC[0-tlast]) After Single Oral Dose of Loratadine
Time frame: 0 hour (h) (pre-dose) to 72 h post-dose
Area under the concentration versus time curve from zero to the last data point greater than (>) LLOQ (AUC[0-tlast]) after single dose.
Maximum Observed Concentration (Cmax) of Loratadine in Plasma After Single Oral Dose of Loratadine
Time frame: 0 h (pre-dose) to 72 h post-dose
Maximum observed loratadine concentration in plasma, directly taken from analytical data.
15 secondary outcomes
Time to Reach Maximum Concentration (tmax) in Plasma After Single Dose of Loratadine
Time frame: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Loratadine in Plasma After Single Dose
Time frame: 0 h (pre-dose) to 72 h post-dose
Half-Life (t1/2) Associated With the Terminal Slope of Loratadine After Single Dose
Time frame: 0 h (pre-dose) to 72 h post-dose
Total Body Clearance (CL/F) of Loratadine Calculated After its Single Oral Administration
Time frame: 0 h (pre-dose) to 72 h post-dose
Percentage of Area Under the Concentration Versus Time Curve (AUC) From the Last Calculated Data Point Greater Than Lower Limit of Quantification [LLOQ]) to Infinity (%AUC[tlast-∞]) After Single Oral Administration of Loratadine
Time frame: 0 h (pre-dose) to 72 h post-dose
Apparent Terminal Rate Constant (λz) of Loratadine After Single Dose
Time frame: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to 72 Hours (AUC[0-72]) of Lloratadine in Plasma After Single Oral Dose
Time frame: 0 h (pre-dose) to 72 h post-dose
Maximum Observed Concentration (Cmax) of Desloratadine in Plasma After Single Oral Dose of Loratadine
Time frame: 0 h (pre-dose) to 72 h post-dose
Time to Reach Maximum Concentration (tmax) of Desloratadine in Plasma After Single Dose of Loratadine
Time frame: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Desoratadine in Plasma (AUC[0-tlast]) After Single Oral Dose of Loratadine
Time frame: 0 h (pre-dose) to 72 h post-dose
Area Under the Concentration Versus Time Curve From Zero to 72 Hours (AUC[0-72]) of Desloratadine in Plasma After Single Oral Dose of Loratadine
Time frame: 0 h (pre-dose) to 72 h post-dose
Time of Last Concentration Above the Lower Limit Of Quantitation (LLOQ) of Desloratadine, Directly Taken From Analytical Data (tlast)
Time frame: 0 h (pre-dose) to 72 h post-dose
Half-Life (t1/2) Associated With the Terminal Slope of Desoratadine After Single Dose of Loratadine
Time frame: 0 h (pre-dose) to 72 h post-dose
Percentage of Area Under the Concentration Versus Time Curve (AUC) from the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) to Infinity (%AUC[tlast-∞]) of Desoratadine After Single Oral Administration of Loratadine
Time frame: 0 h (pre-dose) to 72 h post-dose
Apparent Terminal Rate Constant (λz) of Desoratadine After Single Dose of Loratadine
Time frame: 0 h (pre-dose) to 72 h post-dose
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 Feb 2017.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
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 oral solution and Loratadine (Claritin peach syrup) in people with Histamine H1 Antagonists, Non-Sedating, run by Bayer at 1 site in Germany.
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 6 inclusion and 11 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 Feb 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 Germany. 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?
Primary: Area Under the Concentration Versus Time Curve From Zero to the Last Data Point Greater Than Lower Limit of Quantitation (LLOQ) of Loratadine in Plasma (AUC[0-tlast]) After Single Oral Dose of Loratadine (time frame: 0 hour (h) (pre-dose) to 72 h post-dose). 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 Feb 2017.