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

NCT ID: NCT02593747

Last Updated: 2017-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-03-31

Brief Summary

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Loratadine oral solution

Intervention Type: DRUG

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)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Loratadine oral solution

Intervention Type: DRUG

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)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Neu-Ulm, Bavaria, Germany

Countries

Germany

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2015-002720-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18199

Identifier Type: -

Identifier Source: org_study_id