Healthy VolunteersPhase 1NCT07300059
Short-Term Glycemic Effects of Liquid Metformin vs Standard Tablets
A Phase 1 study testing Liquid Metformin 100 mg/mL, Liquid Metformin 250 mg/mL and Standard Metformin Immediate-Release Tablet in people with Healthy Volunteers, run by Aspargo Labs, Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Liquid Metformin 100 mg/mL, Liquid Metformin 250 mg/mL and Standard Metformin Immediate-Release Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 28 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Pregnant or breastfeeding females.
- Women of childbearing potential not using acceptable contraception.
- Any condition that, in the opinion of the investigator, would make the participant unsuitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Short-Term Glycemic Effects of Two Concentrations of Liquid Metformin Versus Standard Metformin Tablets in Healthy Adults
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.
- Conditions
- Healthy Volunteers
- Being tested
- Liquid Metformin 100 mg/mL, Liquid Metformin 250 mg/mL, Standard Metformin Immediate-Release Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Metformin 100 mg/mLDrug
A single oral dose of a liquid metformin formulation at a concentration of 100 mg/mL will be administered under fasting conditions in one period of the crossover to assess short-term glycemic effects and safety.
Liquid Metformin 250 mg/mLDrug
A single oral dose of a liquid metformin formulation at a concentration of 250 mg/mL will be administered under fasting conditions in one period of the crossover to assess short-term glycemic effects and safety.
Standard Metformin Immediate-Release TabletDrug
A single oral dose of standard metformin immediate-release tablet(s) will be administered under fasting conditions in one period of the crossover to assess short-term glycemic effects and safety.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Crossover | Experimental | Not described Receives: Drug: Liquid Metformin 100 mg/mL; Drug: Liquid Metformin 250 mg/mL; Drug: Standard Metformin Immediate-Release Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Blood Glucose-Time Curve from 0 to 4 Hours Postdose (Glucose AUC₀-₄h)
Measured: 0 to 4 hours after each study dose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start15 Jul 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Aspargo Labs, IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspargo Labs, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300059
- Sponsor's protocol ID
- ASP-020-Met
- Status last verified
- Nov 2025
- First submitted
- 10 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Glycemic Effects of Two Concentrations of Liquid Metformin Versus Standard Metformin Tablets in Healthy Adults
- ClinicalTrials.gov ID
- NCT07300059
- Acronym / sponsor ID
- ASP-020-Met
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Aspargo Labs, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Crossover | Experimental | Drug: Liquid Metformin 100 mg/mL, Drug: Liquid Metformin 250 mg/mL, Drug: Standard Metformin Immediate-Release Tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid Metformin 100 mg/mLA single oral dose of a liquid metformin formulation at a concentration of 100 mg/mL will be administered under fasting conditions in one period of the crossover to assess short-term glycemic effects and safety. | Drug | Single-Arm Crossover |
| Liquid Metformin 250 mg/mLA single oral dose of a liquid metformin formulation at a concentration of 250 mg/mL will be administered under fasting conditions in one period of the crossover to assess short-term glycemic effects and safety. | Drug | Single-Arm Crossover |
| Standard Metformin Immediate-Release TabletA single oral dose of standard metformin immediate-release tablet(s) will be administered under fasting conditions in one period of the crossover to assess short-term glycemic effects and safety. | Drug | Single-Arm Crossover |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liquid Metformin 100 mg/mL, Liquid Metformin 250 mg/mL and Standard Metformin Immediate-Release Tablet in people with Healthy Volunteers, run by Aspargo Labs, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avi Guralnik (17189381157, avi.berg@synergy-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.