We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 16, 2009
First Posted Date  ICMJE September 30, 2009
Results First Submitted Date  ICMJE November 16, 2011
Results First Posted Date  ICMJE December 19, 2011
Last Update Posted Date December 19, 2011
Study Start Date  ICMJE October 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2009)
Sanctura XR® and Glucophage pharmacokinetics when administered each alone and in combination with each other [ Time Frame: Group A: Day 4, 17 and 21; Group B: Day 10, 14, and 27 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects
Official Title  ICMJE Safety and Tolerability of Trospium Chloride Metformin Hydrochloride in Healthy Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Trospium Chloride (Sanctura XR®)
    extended release, 60 mg, oral daily
    Other Name: Sanctura XR® 60 mg
  • Drug: Metformin hydrochloride (Glucophage®)
    immediate release, 500mg
    Other Name: Glucophage®
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Metformin hydrochloride (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.
    Intervention: Drug: Trospium Chloride (Sanctura XR®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2009)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00986401
Other Study ID Numbers  ICMJE MA-SXR-09-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Allergan
Original Responsible Party Vice President Medical Affairs, Allergan, Inc.
Current Study Sponsor  ICMJE Allergan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP