Study is no longer required by Brazil health authority.
A Randomized, Crossover, Double-Blind Study To Evaluate The Safety Of An Association Of Phenylephrine Hydrochloride 10mg + Acetaminophen 500mg + Dimethindene Maleate 1 Mg Compared To Phenylephrine Hydrochloride 10mg In Healthy Volunteers
Sponsor study identifier
interventional
0
1 country
1
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedThis study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 4, 2009
Actual (reported)December 7, 2009
Actual (reported)September 2010
Date type not reportedThis date has not been verified as actual or estimated.
November 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs
15 days
Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing
15 days
To report and evaluate adverse events
15 days
Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
Phenylephrine hydrochloride 10mg
Phenylephrine HCL 10mg
Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordScentryphar Pesquisa Clinica Ltda.
Campinas, São Paulo, Brazil
Novartis Biociências S.A
Novartis
0 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2009
First Posted
December 7, 2009
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Phenylephrine Pediatric Pharmacokinetic Study
Contact the study team to confirm eligibility.
Primary Completion
November 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 3, 2016
Record last verified: 2016-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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