Liquid Metformin 100 mg/mL
DrugA 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.
NCT Number: NCT07300059
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.
Trial opening soon.
Get Notified18 year–55 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
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.
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.
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.
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.
Time frame: 0 to 4 hours after each study dose in each treatment period
Contact information is provided by the study sponsor or research team.
Aspargo Labs, Inc
Industry
Short-Term Glycemic Effects of Two Concentrations of Liquid Metformin Versus Standard Metformin Tablets in Healthy Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07504601
Healthy Volunteers, Neurologic Manifestations
Bethesda, Maryland, United States
View Trial DetailsNCT06868914
Chemically-Induced Disorders, Healthy Volunteers
Baltimore, Maryland, United States
View Trial DetailsNCT07719218
Healthy Volunteers, Interstitial Lung Disease (ILD)
View Trial DetailsNCT07709741
Basal Ganglia Diseases, Brain Diseases
Minneapolis, Minnesota, United States
View Trial Details