Healthy VolunteersPhase 1NCT07300046
Tolerability Study of Liquid Metformin (100 and 250 mg/mL) vs IR 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 tolerability 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 Jun 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, clinical laboratory evaluations, and 12-lead ECG, in the opinion of the investigator.
- Non-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.
- Able to provide written informed consent before any study-specific procedures are conducted.
- Willing and able to comply with all study requirements, including fasting, dosing restrictions, and safety/tolerability assessments.
- 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 clinically significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disease that, in the investigator's opinion, could interfere with participation or data interpretation.
- Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m², or any clinically significant abnormal clinical laboratory findings.
- Prior history of lactic acidosis.
- Current or recent (within 14 days before first dose) use of prescription drugs, over-the-counter medications, herbal products, or dietary supplements, unless approved by the investigator.
- Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
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- Positive urine drug screen or positive alcohol breath test at screening or at check-in.
- Participation in another clinical trial or receipt of an investigational drug or device within 30 days or 5 half-lives (whichever is longer) before 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 or finding that, in the opinion of the investigator, would make the subject 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: A Randomized Study to Assess the Tolerability Profile of Two Concentrations of Liquid Metformin (100 mg/mL and 250 mg/mL) Compared With Standard Metformin Tablets
This is an open-label, randomized study evaluating the tolerability 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. Each participant will receive single oral doses of study treatments in a randomized sequence. Safety and tolerability will be assessed through adverse event monitoring, gastrointestinal symptom evaluations, vital signs, clinical laboratory tests, and ECGs.
- 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 tolerability 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 tolerability and safety.
Standard Metformin Immediate-Release TabletDrug
A single oral dose of standard immediate-release metformin tablet(s) will be administered under fasting conditions in one period of the crossover to assess tolerability 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.
Incidence of Gastrointestinal Treatment-Emergent Adverse Events (GI TEAEs)
Measured: From each study dose through 24 hours postdose in each treatment period
Severity of Gastrointestinal Treatment-Emergent Adverse Events
Measured: From each study dose through 24 hours postdose 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 Jun 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
- Supportive care
- 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
- NCT07300046
- Sponsor's protocol ID
- ASP-019-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
- A Randomized Study to Assess the Tolerability Profile of Two Concentrations of Liquid Metformin (100 mg/mL and 250 mg/mL) Compared With Standard Metformin Tablets
- ClinicalTrials.gov ID
- NCT07300046
- Acronym / sponsor ID
- ASP-019-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 Jun 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 tolerability 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. Each participant will receive single oral doses of study treatments in a randomized sequence. Safety and tolerability will be assessed through adverse event monitoring, gastrointestinal symptom evaluations, vital signs, clinical laboratory tests, and ECGs.
Study design
- Primary purpose
- Supportive care
- 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 (7 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, clinical laboratory evaluations, and 12-lead ECG, in the opinion of the investigator.
- Non-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.
- Able to provide written informed consent before any study-specific procedures are conducted.
Key exclusion criteria (12 listed)
- Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.
- History or presence of clinically significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disease that, in the investigator's opinion, could interfere with participation or data interpretation.
- Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m², or any clinically significant abnormal clinical laboratory findings.
- Prior history of lactic acidosis.
- Current or recent (within 14 days before first dose) use of prescription drugs, over-the-counter medications, herbal products, or dietary supplements, unless approved by the investigator.
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 tolerability 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 tolerability and safety. | Drug | Single-Arm Crossover |
| Standard Metformin Immediate-Release TabletA single oral dose of standard immediate-release metformin tablet(s) will be administered under fasting conditions in one period of the crossover to assess tolerability and safety. | Drug | Single-Arm Crossover |
Primary outcome
Incidence of Gastrointestinal Treatment-Emergent Adverse Events (GI TEAEs)
Time frame: From each study dose through 24 hours postdose in each treatment period
Severity of Gastrointestinal Treatment-Emergent Adverse Events
Time frame: From each study dose through 24 hours postdose 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 7 inclusion and 12 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?
Incidence of Gastrointestinal Treatment-Emergent Adverse Events (GI TEAEs) (time frame: From each study dose through 24 hours postdose in each treatment period). The study lists 2 primary outcomes in all. 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.