NCT02593747 (Bordeaux) is a Phase 1 clinical trial of Loratadine oral solution in Histamine H1 Antagonists, Non-Sedating, sponsored by Bayer.

Who is sponsoring NCT02593747?

NCT02593747 is sponsored by Bayer.

What drugs are being tested in NCT02593747?

Interventions in NCT02593747: Loratadine oral solution, Loratadine (Claritin peach syrup).

What condition does NCT02593747 study?

NCT02593747 studies Histamine H1 Antagonists, Non-Sedating.

Is NCT02593747 still recruiting?

NCT02593747 is currently completed. Last updated 10 February 2017.

Last reviewed 2017-02-10 · How we verify

NCT02593747: Bordeaux

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Completed Phase 1 Last updated 10 February 2017

What this trial tests

Phase 1 trial testing Loratadine oral solution in Histamine H1 Antagonists, Non-Sedating in 54 participants. Completed in 1 March 2016.

Timeline

1 December 2015

Primary endpoint
1 January 2016

1 March 2016

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	1 December 2015
Primary completion	1 January 2016
Estimated completion	1 March 2016
Sites	1 location across Germany

Drugs / interventions tested

Loratadine oral solution — full drug profile →
Loratadine (Claritin peach syrup) — full drug profile →

Conditions studied

Histamine H1 Antagonists, Non-Sedating — all drugs for Histamine H1 Antagonists, Non-Sedating →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 55, any sex, with Histamine H1 Antagonists, Non-Sedating. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02593747 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 10 February 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02593747.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing