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| Name | Class |
|---|---|
| Vizera d.o.o. | INDUSTRY |
| ADM, Ambulanta družinske medicine, Ljubljana, Slovenia | UNKNOWN |
| Adrialab d.o.o., Ljubljana, Slovenia | UNKNOWN |
| Tishcon Corp., USA |
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The single-center, randomized, open-label, five-period crossover single-dose bioavailability study with five CoQ10 formulations
The single-center, randomized, open-label, five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Study will be conducted with single dose CoQ10 to assess bioavailability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard product (SP): USP CoQ10 powder, hard capsules | Active Comparator | 100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10 |
|
| Investigational product 1 (IP1): CoQ10 in soybean oil, softgels | Experimental | 100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10 |
|
| Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels | Experimental | 100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10 |
|
| Investigational product 3 (IP3): Qunol Mega Ubiquinol, softgels | Experimental | 100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10 |
|
| Investigational product 4 (IP4): HydroQsorb Coenzyme Q10, hard capsules | Experimental | 100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose intervention with Standard product (SP) | Dietary Supplement | 2 capsules - 200 mg total CoQ10 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative single dose bioavailability (AUC48) of IP (in comparison to SP) | Relative bioavailability between the investigational products and the standard product (IP1 vs. SP, IP2 vs. SP, IP3 vs. SP, and IP4 vs. SP) expressed as ratio of baseline corrected AUC0-72h, i.e. area under the plasma concentration curve from the administration time to the last observation point (72h) of CoQ10 plasma concentrations above the baseline value. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Relative single dose bioavailability (AUCinf) of IP (in comparison to SP) | Relative bioavailability between the investigational products and the standard product (IP1 vs. SP, IP2 vs. SP, IP3 vs. SP, and IP4 vs. SP) expressed as ratio of baseline corrected AUCinf, i.e. extrapolated area under the CoQ10 plasma concentration curve above the baseline CoQ10 concentration. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Relative single dose bioavailability (AUC48) among all the investigational products | Relative bioavailability among all the investigational products (IP1 vs. IP2, IP1 vs. IP3, IP1 vs. IP4, IP2 vs. IP3, IP2 vs. IP4, and IP3 vs. IP4) expressed as ratio of baseline corrected AUC0-72h, i.e. area under the plasma concentration curve from the administration time to the last observation point (72h) of CoQ10 plasma concentrations above the baseline value. |
Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Igor Pravst | Nutrition Institute, Ljubljana | Principal Investigator |
| Tina Modrej Zadnikar | ADM, Ambulanta družinske medicine, Ljubljana, Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ADM, ambulanta družinske medicine, Ljubljana, Slovenia | Ljubljana | 1000 | Slovenia |
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| UNKNOWN |
Five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Subjects will test 5 formulations of single dose CoQ10 with 2 week wash-out. to assess bioavailability.
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| Single dose intervention with Investigational product (IP1) | Dietary Supplement | 2 softgels - 200 mg total CoQ10 |
|
| Single dose intervention with Investigational product (IP2) | Dietary Supplement | 2 softgels - 200 mg total CoQ10 |
|
| Single dose intervention with Investigational product (IP3) | Dietary Supplement | 2 softgels - 200 mg total CoQ10 |
|
| Single dose intervention with Investigational product (IP4) | Dietary Supplement | 2 capsules - 200 mg total CoQ10 |
|
| 72 hours |
| Relative single dose bioavailability (AUCinf) among all investigational products | Relative bioavailability among all investigational products (IP1 vs. IP2, IP1 vs. IP3, IP1 vs. IP4, IP2 vs. IP3, IP2 vs. IP4, and IP3 vs. IP4) expressed as ratio of baseline corrected AUCinf, i.e. extrapolated area under the CoQ10 plasma concentration curve above the baseline CoQ10 concentration. | 72 hours |
| ID | Term |
|---|---|
| D008722 | Methods |
| D051550 | I-kappa B Kinase |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D017346 | Protein Serine-Threonine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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