NCT07300059
Not yet recruiting
Phase 1
Short-Term Glycemic Effects of Two Concentrations of Liquid Metformin Versus Standard Metformin Tablets in Healthy Adults
Aspargo Labs, Inc0 sites24 target enrollmentStarted: July 15, 2026Last updated:
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Aspargo Labs, Inc
- Enrollment
- 24
- Primary Endpoint
- Area Under the Blood Glucose-Time Curve from 0 to 4 Hours Postdose (Glucose AUC₀-₄h)
Overview
Brief Summary
This is an open-label, randomized study evaluating the short-term glycemic effects of two concentrations of liquid metformin formulations (100 mg/mL and 250 mg/mL) compared with standard immediate-release metformin tablets in healthy adult subjects. Participants will receive single or short-term doses of study treatments in a randomized sequence. Blood glucose measurements and other glycemic indicators will be collected to assess short-term pharmacodynamic effects. Safety and tolerability will also be monitored.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •\- Male or female adults 18 to 55 years of age, inclusive.
- •Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
- •Medically healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator.
- •Fasting blood glucose within the normal reference range at screening.
- •Non-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during each study confinement period.
- •Able to understand and provide written informed consent before participation.
- •Willing and able to comply with all study procedures, including fasting requirements, glycemic assessments, and timed blood draws.
- •Females of childbearing potential must use acceptable contraception as determined by the investigator.
Exclusion Criteria
- •Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.
- •History or presence of any clinically significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric condition that, in the investigator's judgment, could interfere with study participation or data interpretation.
- •Fasting blood glucose outside the normal reference range at screening, or any history of hypoglycemia or glucose regulation disorders.
- •Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m² or any clinically significant abnormal clinical laboratory results.
- •History of lactic acidosis.
- •Use of prescription medications, over-the-counter medications, vitamins, herbal supplements, or dietary supplements within 14 days before first study dosing, unless approved by the investigator.
- •Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
- •Positive urine drug screen or positive alcohol breath test at screening or admission.
- •Participation in another clinical study or receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before the first study dose.
- •Donation of ≥450 mL of blood, or significant blood loss, within 8 weeks before the first study dose.
Arms & Interventions
Single-Arm Crossover
Experimental
Intervention: Liquid Metformin 100 mg/mL (Drug)
Single-Arm Crossover
Experimental
Intervention: Liquid Metformin 250 mg/mL (Drug)
Single-Arm Crossover
Experimental
Intervention: Standard Metformin Immediate-Release Tablet (Drug)
Outcomes
Primary Outcomes
Area Under the Blood Glucose-Time Curve from 0 to 4 Hours Postdose (Glucose AUC₀-₄h)
Time Frame: 0 to 4 hours after each study dose in each treatment period
Secondary Outcomes
No secondary outcomes reported
Investigators
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