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

NCT00986401 | Completed Phase 1 Results

• 1 other identifier: MA-SXR-09-002
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®

  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.

  34 Days

Secondary Outcomes (1)

• Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®

  34 Days

Study Arms (2)

Glucophage® then Sanctura XR® (AB)

EXPERIMENTAL

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®)

Sanctura XR® then Glucophage® (BA)

EXPERIMENTAL

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®)

Interventions

Trospium Chloride (Sanctura XR®) DRUG

extended release, 60 mg, oral daily

Also known as: Sanctura XR® 60 mg

Sanctura XR® then Glucophage® (BA)

Metformin hydrochloride (Glucophage®) DRUG

immediate release, 500mg

Also known as: Glucophage®

Glucophage® then Sanctura XR® (AB)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Tempe, Arizona, United States

Location

MeSH Terms

Interventions

trospium chloride; Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 30, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 19, 2011
• Results First Posted: December 19, 2011

Record last verified: 2011-11

Locations

US (1)