Pharmacokinetic and Safety Study of Metronidazole Oral Suspension in Pediatric Patients With Anaerobic Bacterial Infection

Part of paid clinical trials in Miami, Florida.

Sponsor
Saptalis Pharmaceuticals LLC
Study ID
NCT07146217
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Bacterial Infections

Eligibility Criteria

Sex
ALL
Age
12 Months - 4 Years
Healthy Volunteers
Not accepted

Interventions

  • Likmez® (metronidazole) Oral Suspension — DRUG
    Each patient will receive 7.5 mg/kg of Likmez® every 6 hours, with a concentration of 100 mg metronidazole/mL

Study Details

This is an open-label, single-arm, pharmacokinetic and safety study of Likmez® in pediatric patients aged 12 months to \<4 years with anaerobic bacterial infection

Key Dates

Start date
Aug 31, 2025
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Likmez® (metronidazole) Oral Suspension

Primary Outcome Measure

Maximum plasma concentration [Cmax] [ Time Frame: Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Bioresearch PartnerMiamiFlorida33155
Tania Franco
[email protected]
307-206-5889
Suzelle Costales
[email protected]
Dr.Octavio Carreno (PRINCIPAL_INVESTIGATOR)
Empire Medical Clinical TrialsMiamiFlorida33183
Estrada Nailan
[email protected]
(786) 667-1617
Yovanny Blanco
[email protected]
Martin Francisco Garrido (PRINCIPAL_INVESTIGATOR)
Aavon Clinical TrialsRichmondTexas77407
Zitiali Alanis
[email protected]
713-282-5600
Prashant Zanzane
[email protected]
Vinita Chandwani (PRINCIPAL_INVESTIGATOR)

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