Safety, Tolerability, and Pharmacokinetic Profile of Grammidin, a Metered Dose Topical Spray in Healthy Volunteers

ConditionPharyngitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorValenta Pharm JSC

About this trial

This study aims to evaluate the safety, tolerability, and pharmacokinetic profile of the Grammidin, a metered dose topical spray, compared to Grammidin lozenges following single administration in healthy volunteers .

Eligibility criteria

Qualifiers

Voluntarily and personally signed informed consent form by a healthy volunteer obtained prior to the conduct of any study-related procedure;

Males and females aged 18 to 45 years (inclusive);

Verified healthy status as demonstrated by the absence of clinically significant abnormalities in medical history, physical examination, laboratory tests, and other diagnostic procedures specified in the protocol;

Blood pressure (BP) level: systolic blood pressure (SBP) from 99 to 129 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mm Hg (inclusive);

Disqualifiers

Withdrawal of the volunteer from further participation in the study;

Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);

Emergence of reasons/situations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);

Volunteers selected for participation in the study who do not meet inclusion/exclusion criteria;

Trial design

Treatments tested in this trial

  • Grammidin neo
  • Grammidin, a metered dose topical spray

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators