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

NCT ID: NCT07300007

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-15

Study Completion Date

2026-05-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

This is a single-arm, three-period, three-treatment crossover study in which all participants receive each metformin formulation in randomized sequence.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single-Arm Crossover

Group Type EXPERIMENTAL

Liquid Metformin 100 mg/mL

Intervention Type DRUG

A single oral dose of liquid metformin at a concentration of 100 mg/mL will be administered under fasting conditions in one treatment period of the crossover.

Liquid Metformin 250 mg/mL

Intervention Type DRUG

A single oral dose of liquid metformin at a concentration of 250 mg/mL will be administered under fasting conditions in one treatment period of the crossover.

Interventions

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Liquid Metformin 100 mg/mL

A single oral dose of liquid metformin at a concentration of 100 mg/mL will be administered under fasting conditions in one treatment period of the crossover.

Intervention Type DRUG

Liquid Metformin 250 mg/mL

A single oral dose of liquid metformin at a concentration of 250 mg/mL will be administered under fasting conditions in one treatment period of the crossover.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aspargo Labs, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Guralnik

Role: CONTACT

Phone: 17189381157

Email: [email protected]

Other Identifiers

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ASP-016-MET

Identifier Type: -

Identifier Source: org_study_id