MedTrace Logo

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

NCT02593747 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-02-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02593747 on ClinicalTrials.gov