Clinical trial NCT02593747: To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Histamine H1 Antagonists, Non-Sedating
Keywords: Allergy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-11-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus Claritin Peach Syrup 1mg/mL (ANNA Formula)


Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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);
  * 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;

Primary outcomes:
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
timeFrame: 0 hour (h) (pre-dose) to 72 h post-dose
measure: Maximum Observed Concentration (Cmax) of Loratadine in Plasma After Single Oral Dose of Loratadine
timeFrame: 0 h (pre-dose) to 72 h post-dose
Secondary outcomes:
measure: Time to Reach Maximum Concentration (tmax) in Plasma After Single Dose of Loratadine
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Loratadine in Plasma After Single Dose
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: Half-Life (t1/2) Associated With the Terminal Slope of Loratadine After Single Dose
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: Total Body Clearance (CL/F) of Loratadine Calculated After its Single Oral Administration
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: 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
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: Apparent Terminal Rate Constant (λz) of Loratadine After Single Dose
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: Area Under the Concentration Versus Time Curve From Zero to 72 Hours (AUC[0-72]) of Lloratadine in Plasma After Single Oral Dose
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: Maximum Observed Concentration (Cmax) of Desloratadine in Plasma After Single Oral Dose of Loratadine
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: Time to Reach Maximum Concentration (tmax) of Desloratadine in Plasma After Single Dose of Loratadine
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: 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
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: 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
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: Time of Last Concentration Above the Lower Limit Of Quantitation (LLOQ) of Desloratadine, Directly Taken From Analytical Data (tlast)
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: Half-Life (t1/2) Associated With the Terminal Slope of Desoratadine After Single Dose of Loratadine
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: 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
timeFrame: 0 h (pre-dose) to 72 h post-dose
measure: Apparent Terminal Rate Constant (λz) of Desoratadine After Single Dose of Loratadine
timeFrame: 0 h (pre-dose) to 72 h post-dose
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
state: Bayern
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: