PK and Relative Bioavailability of Liquid Metformin vs Tablets in Healthy Adults
ConditionHealthy Volunteer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAspargo Labs, Inc
About this trial
The study will evaluate the pharmacokinetics and relative bioavailability of two liquid metformin formulations (100 mg/mL and 250 mg/mL)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female adults 18 to 55 years of age, inclusive.
Disqualifiers
Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.
Trial design
Design model
Crossover
Treatments tested in this trial
Liquid Metformin 100 mg/mL
DrugA single oral dose of liquid metformin at a concentration of 100 mg/mL will be administered under fasting conditions in one treatment period of the crossover.
Liquid Metformin 250 mg/mL
DrugA single oral dose of liquid metformin at a concentration of 250 mg/mL will be administered under fasting conditions in one treatment period of the crossover.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Single-Arm CrossoverExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Maximum Observed Plasma Concentration (Cmax)
Time frame
Up to approximately 24 to 36 hours postdose in each treatment period2
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t)
Time frame
Up to approximately 24 to 36 hours postdose in each treatment periodLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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