Trial Outcomes & Findings for Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects (NCT NCT00986401)
NCT ID: NCT00986401
Last Updated: 2011-12-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
34 Days
Results posted on
2011-12-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1
STARTED
|
22
|
22
|
|
Period 1
COMPLETED
|
22
|
21
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
|
Period 2
STARTED
|
22
|
21
|
|
Period 2
COMPLETED
|
22
|
21
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Glucophage® Then Sanctura XR® (AB)
n=22 Participants
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.
|
Sanctura XR® Then Glucophage® (BA)
n=22 Participants
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.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
31.0 years
n=5 Participants
|
30.2 years
n=7 Participants
|
31.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 34 DaysPopulation: Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.
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.
Outcome measures
| Measure |
Glucophage®
n=43 Participants
Glucophage®
|
Glucophage® + Sanctura XR®
n=43 Participants
Glucophage® + Sanctura XR®
|
|---|---|---|
|
Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®
|
739 Nanograms per milliliter (ng/mL)
Standard Deviation 263
|
753 Nanograms per milliliter (ng/mL)
Standard Deviation 252
|
SECONDARY outcome
Timeframe: 34 DaysPopulation: Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.
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.
Outcome measures
| Measure |
Glucophage®
n=44 Participants
Glucophage®
|
Glucophage® + Sanctura XR®
n=43 Participants
Glucophage® + Sanctura XR®
|
|---|---|---|
|
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
|
1.17 Nanograms per milliliter (ng/mL)
Standard Deviation 0.71
|
Adverse Events
Glucophage®
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Sanctura XR®
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sanctura XR® in Combination With Glucophage®
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Glucophage®
n=43 participants at risk
Glucophage®
|
Sanctura XR®
n=44 participants at risk
Sanctura XR®
|
Sanctura XR® in Combination With Glucophage®
n=44 participants at risk
Sanctura XR® in combination with Glucophage®
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.0%
3/43
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
0.00%
0/44
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
0.00%
0/44
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
3/43
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
0.00%
0/44
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
6.8%
3/44
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
|
Nervous system disorders
Headache
|
9.3%
4/43
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
6.8%
3/44
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
15.9%
7/44
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/43
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
0.00%
0/44
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
6.8%
3/44
The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place