Clinical trial NCT00986401: Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects
Official title: Safety and Tolerability of Trospium Chloride Metformin Hydrochloride in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Adults
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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 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.

Primary outcomes:
measure: Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®
timeFrame: 34 Days
Secondary outcomes:
measure: Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®
timeFrame: 34 Days
Other outcomes:
Locations:
city: Tempe
country: United States
state: Arizona
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: