Status:
COMPLETED
Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects
Lead Sponsor:
Allergan
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00986401
Start Date
October 1 2009
End Date
November 1 2009
Last Update
December 19 2011
Active Locations (1)
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1
Tempe, Arizona, United States