Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects
Condition: Healthy
Intervention: Trospium Chloride (Sanctura XR®); Metformin hydrochloride (Glucophage®)
Intervention description: extended release, 60 mg, oral daily; immediate release, 500mg
Intervention MeSH terms: Metformin; Trospium chloride
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adults

Summary:

      The purpose of this study is to investigate the safety and tolerability of trospium chloride
      (Sanctura XR™) and metformin hydrochloride (Glucophage) when co-administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Weight within +/-30% of ideal body weight for height and frame size

          -  Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine
             patches, etc., for 1 months prior to the screening visit).

          -  Willing to abstain from caffeine-containing food and beverages for 24-hours prior to
             dosing, alcohol-containing food and beverage for 48 hours prior to dosing, and Seville
             oranges (eg orange marmalade), grapefruit, or grapefruit juice for 7 days prior to the
             dosing and abstain from all throughout the study.

          -  Willing to abstain from taking medications (with the exception of hormonal
             contraceptives) and nonprescription medication including vitamins, food supplements,
             and herbal preparations for 7 days prior to Day-1 of the first treatment period and
             throughout the study.

        Exclusion Criteria:

          -  Uncontrolled systemic disease

          -  Known allergy or sensitivity to the study medication(s) (Trospium, Metformin)or its
             components

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of entry into this study.

          -  History of myasthenia gravis or closed-angle glaucoma.

          -  Considering or scheduled to undergo any surgical procedure during the study.

          -  History of alcohol or substance abuse within 1 year prior to Day-1 of the first
             treatment period.

          -  History of serious mental or physical illness.

          -  Donated in excess of 500 mL of blood in the 30 days prior to the screening visit.

          -  Required treatment with any medications, either prescription or nonprescription
             (including vitamins, antacids, acid-reducers, food supplements, and herbal
             preparations, excluding hormonal contraceptives), within 7 days prior to Day-1 of the
             first treatment period during the study.

          -  Had an acute illness within 5 days prior to Day-1 of the treatment period.

          -  Had a history of hepatitis B or C, a positive test for hepatitis B surface antigen,
             hepatitis C antibody, a history of human immunodeficiency virus (HIV) infection or
             demonstration of HIV antibodies.

          -  Planned radiologic study requiring intravenous contrast administration of iodinated
             contrast material during the study period Serum Creatinine greater than 1.4 mg/dL.