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To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup (Bordeaux)

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ClinicalTrials.gov Identifier: NCT02593747
Recruitment Status : Completed
First Posted : November 1, 2015
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE October 30, 2015
First Posted Date  ICMJE November 1, 2015
Last Update Posted Date February 13, 2017
Study Start Date  ICMJE December 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
  • Plasma concentration of loratadine characterized by Cmax [ Time Frame: Pre-dose (within 1 hour predose) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose ]
    Maximum observed drug concentration in measured matrix after single dose administration
  • Plasma concentration of loratadine characterized by AUC (t-last) [ Time Frame: Pre-dose (within 1 hour predose) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose ]
    AUC from time 0 to the last data point > lower limit of quantitation (LLOQ)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
  • Time to Reach Maximum Concentration (tmax) in Plasma After Single Dose of Loratadine [ Time Frame: 0 h (pre-dose) to 72 h post-dose ]
    Time to reach maximum loratadine concentration in plasma after its single oral dose, directly taken from analytical data.
  • 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 ]
    Area under the concentration versus time curve from zero to infinity after single 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 ]
    Half-life associated with the terminal slope.
  • Total Body Clearance (CL/F) of Loratadine Calculated After its Single Oral Administration [ Time Frame: 0 h (pre-dose) to 72 h post-dose ]
    Total body clearance of loratadine calculated after extravascular application.
  • 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 ]
    Percentage of AUC from the last calculated data point > LLOQ to infinity was measured.
  • Apparent Terminal Rate Constant (λz) of Loratadine After Single Dose [ Time Frame: 0 h (pre-dose) to 72 h post-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.
  • 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 ]
    Area under the concentration versus time curve from zero to 72 h after single 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 ]
    Maximum observed desloratadine concentration in plasma, directly taken from analytical data.
  • 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 ]
    Time to reach maximum drug concentration in the measured matrix, directly observed from the analytical data.
  • 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 the last data point > LLOQ (AUC[0-tlast]) after single 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 ]
    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.
  • 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 ]
    Time of last concentration above LLOQ, directly taken from analytical data.
  • 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 ]
    Half-life associated with the terminal slope.
  • 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 ]
    Percentage of area under the concentration versus time curve from zero to the last data point > LLOQ in plasma (AUC[(0-tlast]) was measured.
  • Apparent Terminal Rate Constant (λz) of Desoratadine After Single Dose of Loratadine [ Time Frame: 0 h (pre-dose) to 72 h post-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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup
Official Title  ICMJE 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)
Brief Summary To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus Claritin Peach Syrup 1mg/mL (ANNA Formula)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Histamine H1 Antagonists, Non-Sedating
Intervention  ICMJE
  • Drug: Loratadine oral solution
    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.
  • 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 any intervention period.
Study Arms  ICMJE
  • Experimental: Loratadine oral solution/syrup then 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.
    Interventions:
    • Drug: Loratadine oral solution
    • Drug: Loratadine (Claritin peach syrup)
  • Experimental: Claritin peach syrup then Loratadine oral solution/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.
    Interventions:
    • Drug: Loratadine oral solution
    • Drug: Loratadine (Claritin peach syrup)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2015)
54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02593747
Other Study ID Numbers  ICMJE 18199
2015-002720-12 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP