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

• 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: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Trospium Chloride (Sanctura XR®); Drug: Metformin hydrochloride (Glucophage®)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Safety and Tolerability of Trospium Chloride Metformin Hydrochloride in Healthy Subjects
• Study Start Date: October 2009
• Actual Primary Completion Date: November 2009
• Actual Study Completion Date: November 2009

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: Metformin hydrochloride (Glucophage®); immediate release, 500mg; Other Name: 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.	Drug: Trospium Chloride (Sanctura XR®); extended release, 60 mg, oral daily; Other Name: Sanctura XR® 60 mg

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Arizona

Tempe, Arizona, United States

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00986401
• Other Study ID Numbers: MA-SXR-09-002
• First Posted: September 30, 2009
• Results First Posted: December 19, 2011
• Last Update Posted: December 19, 2011
• Last Verified: November 2011

Keywords provided by Allergan:

Adults

Additional relevant MeSH terms:

Metformin; Trospium chloride; Hypoglycemic Agents; Physiological Effects of Drugs; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents