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

NCT ID: NCT00986401

Last Updated: 2011-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2009-11-30

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.

Conditions

Healthy

Keywords

Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Metformin hydrochloride (Glucophage®)

Intervention Type: DRUG

immediate release, 500mg

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.

Group Type: EXPERIMENTAL

Trospium Chloride (Sanctura XR®)

Intervention Type: DRUG

extended release, 60 mg, oral daily

Interventions

Trospium Chloride (Sanctura XR®)

extended release, 60 mg, oral daily

Intervention Type: DRUG

Metformin hydrochloride (Glucophage®)

immediate release, 500mg

Intervention Type: DRUG

Other Intervention Names

Sanctura XR® 60 mg; Glucophage®

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Tempe, Arizona, United States

Countries

United States

Other Identifiers

MA-SXR-09-002

Identifier Type: -

Identifier Source: org_study_id