TOLERABILITY OF A NEW FORMULATION OF ARGOTONE IN HEALTH VOLONTEERS - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005576-32-IT

Enrollment

Registered

2006-02-06

Start date

2005-12-19

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis and nasal congestion MedDRA version: 6.1 Level: PT Classification code 10047482

Interventions

Pharmaceutical Form: Nasal spray, solution INN or Proposed INN: Ephedrine CAS Number: 50-98-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .81-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female Age between 18 and 65 years Weight between /- 10 of normal value Metropolitan Height and Weight Tables Written informed consense obtained Use of contaception if female Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Smokers more than 10 cigarettes / die Severe concomitant pathologies Allergy to IMP components Alcohol, coffee and tea abuse Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluating the incidence of possible sistemic adverse events of the new nasal spray formulation of Argotone;Secondary Objective: Evaluating the incidence of possible local adverse events of the new nasal spray formulation of Argotone;Primary end point(s): Sistemic pressure Oculare tone Epatic function Rhinoscopy	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026