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| Name | Class |
|---|---|
| Vizera d.o.o. | INDUSTRY |
| Valens Int. d.o.o., Slovenija | INDUSTRY |
| MEDEDUS, Ljubljana, Slovenia | UNKNOWN |
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The single-center, randomized, open-label, three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard product group | Active Comparator | This group will be included in a single dose cross over study, and in multiple dose study with standard product (SP: CoQ10 hard capsules; 100 mg) |
|
| Comparative product group | Active Comparator | This group will be included in a single dose cross over study, and in multiple dose study with comparative product (CP: CoQ10 soft-gel capsules; 100 mg) |
|
| Investigational product group | Experimental | This group will be included in a single dose cross over study, and in multiple dose study with investigational product (IP: CoQ10 syrup; 100 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose intervention with Standard product (SP) | Dietary Supplement | hard capsules, 100 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| improved single dose bioavailability of IP (in comparison to SP) | Relative bioavailability between the investigational and standard product expressed as ratio of AUC0-48h (area under the plasma concentration curve from the administration time to the last observation point, i.e. 48h) of total CoQ10 plasma concentrations above the baseline value. | 48 hours |
| improved plasma CoQ10 level after multiple dose study for IP (in comparison to SP) | Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational and standard product. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| comparable single dose bioavailability of IP (in comparison to CP) | Relative bioavailability between the investigational product and comparator expressed as ratio of AUC0-48h of total CoQ10 plasma concentrations above the baseline value. | 48 hours |
| comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Igor Pravst | Nutrition Institute, Ljubljana | Principal Investigator |
| Snežana Kocijančič | MEDEDUS, Ljubljana, Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MEDEDUS, Ljubljana, Slovenia | Ljubljana | 1000 | Slovenia | |||
| Nutrition Institute, Ljubljana |
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Three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.
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| Single dose intervention with Comparative product (CP) | Dietary Supplement | soft-gel capsules, 100 mg |
|
| Single dose intervention with Investigational product (IP) | Dietary Supplement | syrup, 100 mg |
|
| Multiple dose intervention with Standard product (SP) | Dietary Supplement | hard capsules, 100 mg - 14 days |
|
| Multiple dose intervention with Comparative product (CP) | Dietary Supplement | soft-gel capsules, 100 mg - 14 days |
|
| Multiple dose intervention with Investigational product (IP) | Dietary Supplement | syrup, 100 mg - 14 days |
|
Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational product and comparator. |
| 14 days |
| Ljubljana |
| 1000 |
| Slovenia |
| Vizera d.o.o., Ljubljana, Slovenia | Ljubljana | 1000 | Slovenia |
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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