Trial Condition(s):

Histamine H1 Antagonists, Non-Sedating

To assess bioequivalence of Loratadine Oral Solution/Syrup versus Claritin Peach Syrup (Bordeaux)

Bayer Identifier:

18199

ClinicalTrials.gov Identifier:

NCT02593747

EudraCT Number:

2015-002720-12

EU CT Number:

Not Available

Study Completed

Trial Purpose

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

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;

Trial Summary

Enrollment Goal
54
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
CLARITIN (Loratadine, BAY76-2211)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Neu-Ulm, Germany, 89231

Status
Completed

Trial Design