Assessing the PK of Met DR, Met IR, and Met XR in Healthy Subjects
Condition: Healthy Subjects
Intervention: Met DR; Met XR; Met IR
Intervention description: metformin delayed-release tablets; metformin extended-release tablets; metformin immediate-release tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 20.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study compared the pharmacokinetics (PK) and assessed the safety of delayed-release
      metformin (Met DR, EFB0027) at two dosage levels, immediate-release metformin (Met IR,
      ETB0015), and extended-release metformin (Met XR, ETB0014) in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 19 to 65 (inclusive) years old at Visit 1 (Screening)

          2. Male, or if female and met all of the following criteria:

               1. Not breastfeeding

               2. Negative pregnancy test result at Visit 1 (Screening) (not applicable to
                  hysterectomized females)

               3. Surgically sterile, postmenopausal, or if of childbearing potential, practiced
                  and was willing to continue to practice appropriate birth control during the
                  entire duration of the study

          3. Body mass index (BMI) of 25.0 to 35.0 kg/m² (inclusive) at Visit 1 (Screening)

          4. Had a physical examination with no clinically significant abnormalities as judged by
             the investigator

          5. Had normal renal function with an estimated glomerular filtration rate (eGFR) ≥90
             mL/min/1.73 m² based on the Modification of Diet in Renal Disease (MDRD) equation

          6. Ability to understand and willingness to adhere to protocol requirements

        Exclusion Criteria:

          1. Had a clinically significant medical condition as judged by the investigator that
             could potentially affect study participation and/or personal well-being, including but
             not limited to the following conditions:

               1. Hepatic disease

               2. Gastrointestinal disease

               3. Endocrine disorder (including diabetes and impaired glucose tolerance)

               4. Cardiovascular disease

               5. Central nervous system diseases

               6. Psychiatric or neurological disorders

               7. Organ transplantation

               8. Chronic or acute infection

               9. Orthostatic hypotension, fainting spells or blackouts

              10. Allergy or hypersensitivity

          2. Had any chronic disease requiring medication that was adjusted in the past 90 days
             (subjects could take acute intermittent over-the-counter medications such as Tylenol,
             if needed)

          3. Had major surgery of any kind within 6 months of Visit 1 (Screening)

          4. Had a history of >6 kg weight change within 3 months of Visit 1 (Screening)

          5. Had clinical laboratory test (clinical chemistry, hematology, or urinalysis)
             abnormalities judged by the investigator to be clinically significant at Visit 1
             (Screening)

          6. Had a physical, psychological, or historical finding that, in the investigator's
             opinion, would make the subject unsuitable for the study

          7. Had any drug treatment that affects gastric pH (prescription or over-the-counter),
             including any antacids or medications such as Rolaids or Pepcid within 2 days of Visit
             1 (Screening)

          8. Currently abused drugs or alcohol or had a history of abuse that in the investigator's
             opinion would cause the individual to be noncompliant with study procedures

          9. Smoked more than 10 cigarettes per day, 3 cigars per day, 3 pipes per day, used more
             than 1 can of smokeless tobacco per week, or used a combination of tobacco products
             that approximate nicotine doses equivalent to 10 cigarettes per day

         10. Had donated blood within 3 months of the date of the first dose of randomized study
             medication, or was planning to donate blood during the study

         11. Had received any investigational drug within 2 months (or five half-lives of the
             investigational drug, whichever was greater) of the date of the first dose of
             randomized study medication

         12. Had known allergies or hypersensitivity to any component of study treatment

         13. Was employed by Elcelyx Therapeutics, Inc (that is an employee, temporary contract
             worker, or designee of the company)