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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Allergan
• Treatments: Metformin; Trospium chloride

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.