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Bioavailability Study of COQUN ORAL FORMULATION

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819491
Recruitment Status : Completed
First Posted : January 28, 2019
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
VISUfarma SpA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Male & Female Healthy Volunteers
Intervention Dietary Supplement: COQUN ORAL FORMULATION
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CoQ10 Once Daily CoQ10 Twice a Day
Hide Arm/Group Description

100 mg OD

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

100 mg BID

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

Period Title: Before Randomization
Started 24 0
Completed 24 0
Not Completed 0 0
Period Title: After Randomization
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title CoQ10 Once Daily CoQ10 Twice a Day Total
Hide Arm/Group Description

100 mg OD

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

100 mg BID

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
35  (7) 43  (7) 39  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
8
  66.7%
8
  66.7%
16
  66.7%
Male
4
  33.3%
4
  33.3%
8
  33.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
12
 100.0%
12
 100.0%
24
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Analysis of Pharmacokinetic Property "Area Under the Curve"
Hide Description

- Area under the curve (microg/ml x h): ≥5

Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.

Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.

Time Frame from day-7 to day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CoQ10 Once Daily CoQ10 Twice a Day
Hide Arm/Group Description:

100 mg OD

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

100 mg BID

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

Overall Number of Participants Analyzed 12 12
Mean (95% Confidence Interval)
Unit of Measure: microg/l*days
2657.45
(2224.3 to 3090.6)
3459.05
(2806.7 to 4111.4)
2.Primary Outcome
Title Analysis of Pharmacokinetic Property "Cmax"
Hide Description

- Cmax: ≥0,8

Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.

Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.

Time Frame from day-7 to day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CoQ10 Once Daily CoQ10 Twice a Day
Hide Arm/Group Description:

100 mg OD

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

100 mg BID

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

Overall Number of Participants Analyzed 12 12
Mean (95% Confidence Interval)
Unit of Measure: microg/l
1163.99
(938.46 to 1389.51)
1501.89
(1200.32 to 1803.47)
3.Primary Outcome
Title Analysis of Pharmacokinetic Property "Tmax"
Hide Description

- Tmax: ≥3

Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.

Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.

Time Frame from day-7 to day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CoQ10 Once Daily CoQ10 Twice a Day
Hide Arm/Group Description:

100 mg OD

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

100 mg BID

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

Overall Number of Participants Analyzed 12 12
Mean (95% Confidence Interval)
Unit of Measure: hours
17.5
(11.07 to 23.93)
16.92
(11.4 to 22.43)
Time Frame AE were collected for the total duration of the study (28 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CoQ10 Once Daily After Randomization CoQ10 Twice a Day After Randomization CoQ10 Once Daily Before Randomization
Hide Arm/Group Description

100 mg OD

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

100 mg BID

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

100 mg OD

COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

All-Cause Mortality
CoQ10 Once Daily After Randomization CoQ10 Twice a Day After Randomization CoQ10 Once Daily Before Randomization
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CoQ10 Once Daily After Randomization CoQ10 Twice a Day After Randomization CoQ10 Once Daily Before Randomization
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CoQ10 Once Daily After Randomization CoQ10 Twice a Day After Randomization CoQ10 Once Daily Before Randomization
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   3/12 (25.00%)   0/24 (0.00%) 
Cardiac disorders       
PULTACEOUS ANGINA *  0/12 (0.00%)  1/12 (8.33%)  0/24 (0.00%) 
Ear and labyrinth disorders       
DIZZINESS *  0/12 (0.00%)  1/12 (8.33%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
RESPIRATORY VIROSIS *  0/12 (0.00%)  1/12 (8.33%)  0/24 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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. Delia Reurean-Pintilei
Organization: Consult Med Iasi
Phone: +40232233387
EMail: drdeliapintilei@gmail.com
Layout table for additonal information
Responsible Party: VISUfarma SpA
ClinicalTrials.gov Identifier: NCT03819491     History of Changes
Other Study ID Numbers: VF-BAQ10/2018
First Submitted: January 23, 2019
First Posted: January 28, 2019
Results First Submitted: May 9, 2019
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019