Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects

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

Official Title
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Safety and Tolerability of Trospium Chloride Metformin Hydrochloride in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Trospium Chloride (Sanctura XR®)
* Drug: Metformin hydrochloride (Glucophage®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucophage® then Sanctura XR® (AB)<br>Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days. | Drug: Metformin hydrochloride (Glucophage®)<br>* immediate release, 500mg<br>* Other names: Glucophage®;|
| Experimental: Sanctura XR® then Glucophage® (BA)<br>Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days. | Drug: Trospium Chloride (Sanctura XR®)<br>* extended release, 60 mg, oral daily<br>* Other names: Sanctura XR® 60 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage® | Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) following oral administration of Glucophage® alone and in combination with SanturaXR®. Plasma is the fluid portion of the blood. | 34 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR® | Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR® alone and in combination with Glucophage®. Plasma is the fluid portion of the blood in which the cells are suspended. | 34 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adults