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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Trospium Chloride (Sanctura XR®); Drug: Metformin hydrochloride (Glucophage®)

• Registration Number: NCT00986401
• Lead Sponsor: Allergan

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 available

Study Timeline

• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Study Start: 2009-10
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2011-11
• Results First Submitted: 2011-11-16
• Results First Submitted QC: 2011-11-16
• Last Update Submitted: 2011-11-16
• Results First Posted: 2011-12-19
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sanctura XR® then Glucophage® (BA)	Trospium Chloride (Sanctura XR®)	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.
Glucophage® then Sanctura XR® (AB)	Metformin hydrochloride (Glucophage®)	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.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®	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

Name	Time	Method
Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®	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.