Trial Outcomes & Findings for Bioavailability Study of COQUN ORAL FORMULATION (NCT NCT03819491)
NCT ID: NCT03819491
Last Updated: 2019-09-06
Results Overview
\- 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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
from day-7 to day 28
Results posted on
2019-09-06
Participant Flow
Participant milestones
| Measure |
CoQ10 Once Daily
100 mg OD
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
CoQ10 Twice a Day
100 mg BID
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
|---|---|---|
|
Before Randomization
STARTED
|
24
|
0
|
|
Before Randomization
COMPLETED
|
24
|
0
|
|
Before Randomization
NOT COMPLETED
|
0
|
0
|
|
After Randomization
STARTED
|
12
|
12
|
|
After Randomization
COMPLETED
|
12
|
12
|
|
After Randomization
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioavailability Study of COQUN ORAL FORMULATION
Baseline characteristics by cohort
| Measure |
CoQ10 Once Daily
n=12 Participants
100 mg OD
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
CoQ10 Twice a Day
n=12 Participants
100 mg BID
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 7 • n=5 Participants
|
43 years
STANDARD_DEVIATION 7 • n=7 Participants
|
39 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from day-7 to day 28\- 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.
Outcome measures
| Measure |
CoQ10 Once Daily
n=12 Participants
100 mg OD
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
CoQ10 Twice a Day
n=12 Participants
100 mg BID
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
|---|---|---|
|
Analysis of Pharmacokinetic Property "Area Under the Curve"
|
2657.45 microg/l*days
Interval 2224.3 to 3090.6
|
3459.05 microg/l*days
Interval 2806.7 to 4111.4
|
PRIMARY outcome
Timeframe: from day-7 to day 28\- 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.
Outcome measures
| Measure |
CoQ10 Once Daily
n=12 Participants
100 mg OD
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
CoQ10 Twice a Day
n=12 Participants
100 mg BID
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
|---|---|---|
|
Analysis of Pharmacokinetic Property "Cmax"
|
1163.99 microg/l
Interval 938.46 to 1389.51
|
1501.89 microg/l
Interval 1200.32 to 1803.47
|
PRIMARY outcome
Timeframe: from day-7 to day 28\- 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.
Outcome measures
| Measure |
CoQ10 Once Daily
n=12 Participants
100 mg OD
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
CoQ10 Twice a Day
n=12 Participants
100 mg BID
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
|---|---|---|
|
Analysis of Pharmacokinetic Property "Tmax"
|
17.5 hours
Interval 11.07 to 23.93
|
16.92 hours
Interval 11.4 to 22.43
|
Adverse Events
CoQ10 Once Daily After Randomization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CoQ10 Twice a Day After Randomization
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CoQ10 Once Daily Before Randomization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CoQ10 Once Daily After Randomization
n=12 participants at risk
100 mg OD
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
CoQ10 Twice a Day After Randomization
n=12 participants at risk
100 mg BID
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
CoQ10 Once Daily Before Randomization
n=24 participants at risk
100 mg OD
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
|
|---|---|---|---|
|
Ear and labyrinth disorders
DIZZINESS
|
0.00%
0/12 • AE were collected for the total duration of the study (28 days).
|
8.3%
1/12 • AE were collected for the total duration of the study (28 days).
|
0.00%
0/24 • AE were collected for the total duration of the study (28 days).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY VIROSIS
|
0.00%
0/12 • AE were collected for the total duration of the study (28 days).
|
8.3%
1/12 • AE were collected for the total duration of the study (28 days).
|
0.00%
0/24 • AE were collected for the total duration of the study (28 days).
|
|
Cardiac disorders
PULTACEOUS ANGINA
|
0.00%
0/12 • AE were collected for the total duration of the study (28 days).
|
8.3%
1/12 • AE were collected for the total duration of the study (28 days).
|
0.00%
0/24 • AE were collected for the total duration of the study (28 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place