NCT07300020

PK and Relative Bioavailability of Novel Liquid Metformin vs Tablets

Single-Dose Pharmacokinetics and Relative Bioavailability of a Novel Liquid Metformin Formulation (100 mg/mL and 250 mg/mL) Compared With Immediate-Release Metformin Tablets in Adult Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Aspargo Labs, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, three-period crossover study evaluating the single-dose pharmacokinetics and relative bioavailability of a novel liquid metformin formulation at concentrations of 100 mg/mL and 250 mg/mL compared with immediate-release metformin tablets in healthy adult subjects. All participants will receive each formulation in randomized sequence with washout periods between treatments. Serial blood samples will be collected to characterize metformin pharmacokinetic parameters, and safety and tolerability will be assessed throughout the study.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Novel Liquid Metformin 100 mg/mL	Single oral dose of a novel liquid metformin formulation at 100 mg/mL administered under fasting conditions in one treatment period.
DRUG	Novel Liquid Metformin 250 mg/mL	Single oral dose of a novel liquid metformin formulation at 250 mg/mL administered under fasting conditions in one treatment period.
DRUG	Metformin Immediate-Release Tablet	Single oral dose of standard immediate-release metformin tablet(s) administered under fasting conditions in one treatment period.

Timeline

• Start date: 2026-04-15
• Primary completion: 2026-06-15
• Completion: 2026-06-28
• First posted: 2025-12-23
• Last updated: 2025-12-23

Regulatory

• FDA-regulated drug study