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Trial record 2 of 456 for:    DICLOFENAC

Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02495831
Recruitment Status : Completed
First Posted : July 13, 2015
Results First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Collaborator:
Cross Research S.A.
Information provided by (Responsible Party):
Zambon SpA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Diclofenac sodium
Drug: Diclofenac sodium and safinamide
Enrollment 24
Recruitment Details The recruitment started and finished on May 2015 and the study was performed in Switzerland at CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 CH-6864 Arzo, Switzerland
Pre-assignment Details Twenty-four (24) subjects were randomised in the study. One of the 24 subjects discontinued the study before study treatment. Twenty-two (22) subjects completed the study per protocol.
Arm/Group Title Diclofenac Sodium First, Safinamide + Diclofenac Sodium Second Safinamide + Diclofenac Sodium First, Diclofenac Sodium Second
Hide Arm/Group Description Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose Diclofenac sodium 50 mg oral tablets, single dose Safinamide 200 mg oral tablets, single dose
Period Title: First Intervention
Started 13 10
Completed 13 10
Not Completed 0 0
Period Title: Second Intervention
Started 12 [1] 10
Completed 12 10
Not Completed 0 0
[1]
One participant withdrew at the end of period 1
Arm/Group Title Intervention
Hide Arm/Group Description

Diclofenac sodium 50 mg oral tablets, single dose

Diclofenac sodium 50 mg oral tablets, single dose and safinamide 200 mg oral tablets, single dose

Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
males and females healthy volunteers, age 22-55 inclusive. This is a cross-over study, so 23 subjects were enrolled in total and participated in both groups
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
23
 100.0%
>=65 years
0
   0.0%
[1]
Measure Description: healthy volunteers, both sexes, 22-55 years old inclusive
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
41.6  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
12
  52.2%
Male
11
  47.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
23
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 23 participants
23
1.Primary Outcome
Title To Evaluate Plasma Diclofenamic Acid Extent of Exposure Reported as Plasma AUC After Single Administration of 50 mg Diclofenac Sodium, With and Without Co-administration of a Single 200 mg Dose of Safinamide.
Hide Description Plasma diclofenamic acid AUC0-t after T2 single dose, with and without T1 co-administration. To measure AUC plasma samples were taken by the participants at different time points, and the concentrations of diclofenac and safinamide were measured. AUC0-t is the area under the concentration-time curve from administration to the last observed concentration time t; PK parameters AUC0-t were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
healthy volunteers
Arm/Group Title Diclofenac Sodium Diclofenac Sodium and Safinamide
Hide Arm/Group Description:

Diclofenac sodium 50 mg oral tablets, single dose

Diclofenac sodium: Diclofenac sodium 50 mg single dose

Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose

Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: h X ng per mL
1323.28  (390.53) 1381.32  (393.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Sodium, Diclofenac Sodium and Safinamide
Comments The PK parameters AUC0-t and Cmax were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments If the upper limit of the 90% confidence interval is < 125.00%, no effect of safinamide on diclofenamic acid bioavailability is present (no interaction present).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter point estimate (ratio of geometric means
Estimated Value 90
Confidence Interval (2-Sided) 90%
80 to 125
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Evaluate Diclofenac Rate of Absorption Reported as Plasma Cmax After Single Administration of 50 mg Diclofenac With and Without 200 mg of Safinamide.
Hide Description Cmax, of plasma diclofenamic acid after T2 single dose, with and without T1 co-administration. The parametric point estimators (PE) for the ratios of T2 treatment with T1 co-administration / T2 treatment without T1 co-administration for the PK parameters under consideration, and the two-sided 90% confidence interval (CI), were calculated using the adjusted least squares means (LSMEANS) from the ANOVA. LSmeans differences obtained in the log scale for Cmax were back-transformed to obtain the PE (i.e. geometric mean ratio) and the two-sided 90% CI as percentages.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Sodium Diclofenac Sodium and Safinamide
Hide Arm/Group Description:

Diclofenac sodium 50 mg oral tablets, single dose

Diclofenac sodium: Diclofenac sodium 50 mg single dose

Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose

Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose

Overall Number of Participants Analyzed 22 22
Least Squares Mean (Standard Deviation)
Unit of Measure: ng/mL
766.59  (390.01) 833.50  (443.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Sodium, Diclofenac Sodium and Safinamide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean ratio
Estimated Value 104.84
Confidence Interval (2-Sided) 90%
96.40 to 114.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Tmax and T1/2
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Sodium Diclofenac Sodium and Safinamide
Hide Arm/Group Description:

Diclofenac sodium 50 mg oral tablets, single dose

Diclofenac sodium: Diclofenac sodium 50 mg single dose

Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose

Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose

Overall Number of Participants Analyzed 22 22
Least Squares Mean (Standard Deviation)
Unit of Measure: hours
Tmax 0.88  (0.41) 1.0  (0.43)
T1/2 1.24  (0.43) 1.19  (0.40)
4.Secondary Outcome
Title Lamda z
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Sodium Diclofenac Sodium and Safinamide
Hide Arm/Group Description:

Diclofenac sodium 50 mg oral tablets, single dose

Diclofenac sodium: Diclofenac sodium 50 mg single dose

Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose

Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: 1/hours
0.63  (0.22) 0.63  (0.16)
5.Secondary Outcome
Title Relative Bioavailability (Frel)
Hide Description calculated as ratio between AUC0-t (test) / AUC0-t (reference)
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac Sodium Diclofenac Sodium and Safinamide
Hide Arm/Group Description:

Diclofenac sodium 50 mg oral tablets, single dose

Diclofenac sodium: Diclofenac sodium 50 mg single dose

Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose

Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ratio
107.67  (28.84) 109.61  (32.14)
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac Sodium Diclofenac Sodium and Safinamide
Hide Arm/Group Description Diclofenac sodium 50 mg oral tablets, single dose Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
All-Cause Mortality
Diclofenac Sodium Diclofenac Sodium and Safinamide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac Sodium Diclofenac Sodium and Safinamide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diclofenac Sodium Diclofenac Sodium and Safinamide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Milko Radicioni
Organization: CROSS REsearch SA
Phone: +41.91.63.00 ext 510
EMail: clinic@croalliance.com
Layout table for additonal information
Responsible Party: Zambon SpA
ClinicalTrials.gov Identifier: NCT02495831     History of Changes
Other Study ID Numbers: Z7219J01
First Submitted: July 3, 2015
First Posted: July 13, 2015
Results First Submitted: January 22, 2016
Results First Posted: April 15, 2016
Last Update Posted: April 15, 2016