Healthy
Conditions
Keywords
Adults
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.
Interventions
DRUGTrospium Chloride (Sanctura XR®)
extended release, 60 mg, oral daily
DRUGMetformin hydrochloride (Glucophage®)
immediate release, 500mg
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | Glucophage® Then Sanctura XR® (AB) | Sanctura XR® Then Glucophage® (BA) | Total |
|---|---|---|---|
| Age Continuous | 31.0 years | 30.2 years | 31.0 years |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 43 | 3 / 44 | 13 / 44 |
| serious Total, serious adverse events | 0 / 43 | 0 / 44 | 0 / 44 |
Outcome results
Primary
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.
Time frame: 34 Days
Population: Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucophage® | Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage® | 739 Nanograms per milliliter (ng/mL) | Standard Deviation 263 |
| Glucophage® + Sanctura XR® | Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage® | 753 Nanograms per milliliter (ng/mL) | Standard Deviation 252 |
Secondary
Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®
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.
Time frame: 34 Days
Population: Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucophage® | Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR® | 1.87 Nanograms per milliliter (ng/mL) | Standard Deviation 1.44 |
| Glucophage® + Sanctura XR® | Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR® | 1.17 Nanograms per milliliter (ng/mL) | Standard Deviation 0.71 |