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

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ClinicalTrials.gov Identifier: NCT00986401
Recruitment Status : Completed
First Posted : September 30, 2009
Results First Posted : December 19, 2011
Last Update Posted : December 19, 2011
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Trospium Chloride (Sanctura XR®) Drug: Metformin hydrochloride (Glucophage®) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Safety and Tolerability of Trospium Chloride Metformin Hydrochloride in Healthy Subjects
Study Start Date : October 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Glucophage® then Sanctura XR® (AB)
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®)
immediate release, 500mg
Other Name: Glucophage®
Experimental: Sanctura XR® then Glucophage® (BA)
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®)
extended release, 60 mg, oral daily
Other Name: Sanctura XR® 60 mg


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage® [ Time Frame: 34 Days ]
    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.


Secondary Outcome Measures :
  1. Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR® [ Time Frame: 34 Days ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986401


Locations
United States, Arizona
Tempe, Arizona, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00986401     History of Changes
Other Study ID Numbers: MA-SXR-09-002
First Posted: September 30, 2009    Key Record Dates
Results First Posted: December 19, 2011
Last Update Posted: December 19, 2011
Last Verified: November 2011

Keywords provided by Allergan:
Adults

Additional relevant MeSH terms:
Metformin
Trospium chloride
Hypoglycemic Agents
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
 Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents