PK and Relative Bioavailability of Liquid Metformin vs Tablets in Healthy Adults

Aspargo Labs, Inc

Status and phase

Begins enrollment in 1 month

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Liquid Metformin 250 mg/mL

Drug: Liquid Metformin 100 mg/mL

Study type

Interventional

Funder types

Industry

Identifiers

NCT07300007

ASP-016-MET

Details and patient eligibility

About

The study will evaluate the pharmacokinetics and relative bioavailability of two liquid metformin formulations (100 mg/mL and 250 mg/mL)

Full description

The study will compare the pharmacokinetic profiles of two liquid metformin formulations (100 mg/mL and 250 mg/mL) with a standard metformin immediate-release tablet.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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 with no clinically significant findings on medical history, physical examination, vital signs, 12-lead ECG, or clinical laboratory tests, in the opinion of the investigator.

Non-smokers or light smokers (10 or fewer cigarettes per day or equivalent) willing to abstain from smoking during confinement.

Able to understand and provide written informed consent before any study procedures are conducted.

Willing and able to comply with all study requirements, including fasting restrictions and visit schedules.

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 clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disorders that could affect study participation or data interpretation.

Estimated glomerular filtration rate (eGFR) less than 90 mL per minute per 1.73 square meters, or any clinically significant abnormal laboratory findings.

History of lactic acidosis.

Use of prescription medications, over-the-counter medications, herbal supplements, or dietary supplements within 14 days before first dosing, unless approved by the investigator.

Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.

Positive urine drug test or positive alcohol breath test at screening or admission.

Participation in another clinical trial or receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before first study dose.

Blood donation of more than 450 mL or significant blood loss within 8 weeks before first dosing.

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.