Health TrialsbyHealthPanel

Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, 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 with anesthetic, a metered dose topical spray, compared to Grammidin with anesthetic neo, lozenges following single administration in healthy volunteers.

Eligibility criteria

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Grammidin with anesthetic neo

    Drug

    Grammidin with anesthetic neo, lozenges, 1 lozenge to be taken once under fed conditions.

  • Grammidin with anesthetic, a metered dose topical spray

    Drug

    Grammidin with anesthetic, a metered dose topical spray, 4 sprays to be taken once under fed conditions

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: RT sequence: Grammidin with anesthetic neo followed by Grammidin with anestheticExperimental treatment 2 interventions
Group B: TR sequence: Grammidin with anesthetic followed by Grammidin with anesthetic neoExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pharmacokinetics - Cmax

Maximum plasma concentration (Cmax) of gramicidin S, oxybuprocaine hydrochloride, and cetylpyridinium chloride. The same analytes would be used for other pharmacokinetic measures listed below.

Time frame
From 0 to 24 hours after each drug intake.
2

Pharmacokinetics - tmax

Time to reach Cmax (tmax)

Time frame
From 0 to 24 hours after each drug intake.
3

Pharmacokinetics - AUC0-t

Area under the plasma concentration-time curve from time 0 to t (AUC0-t)

Time frame
From 0 to 24 hours after each drug intake.
4

Pharmacokinetics - AUC0-inf

Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)

Time frame
From 0 hours after each drug intake (extrapolated to infinity)

Secondary outcomes

1

Adverse event type

Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.

Time frame
From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
2

Adverse event number

Number of adverse events registered during the study

Time frame
From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
3

Adverse event severety

Severity of adverse events registered during the study

Time frame
From screeninig (days -14 to -1) to the end of study (day 15 ± 1)
4

Drop-outs associated with adverse events

The number of cases of early termination of participation in the study due to the development of adverse events and/or serious adverse events associated with the study drug

Time frame
From screeninig (days -14 to -1) to the end of study (day 15 ± 1)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Valenta Pharm JSC

Lead sponsor

Source ClinicalTrials.gov
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