An interventional study of Single dose intervention with Standard product (SP) and Single dose intervention with Investigational product (IP1) in Bioavailability of Coenzyme Q10, sponsored by Nutrition Institute, Slovenia. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-14.
Sponsored by Nutrition Institute, Slovenia · Not applicable, Interventional, and Other
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.
Nutrition Institute, Slovenia is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10
Dietary Supplement: Single dose intervention with Standard product (SP)
100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10
Dietary Supplement: Single dose intervention with Investigational product (IP1)
100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10
Dietary Supplement: Single dose intervention with Investigational product (IP2)
100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10
Dietary Supplement: Single dose intervention with Investigational product (IP3)
100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10
Dietary Supplement: Single dose intervention with Investigational product (IP4)
2 capsules - 200 mg total CoQ10
2 softgels - 200 mg total CoQ10
2 softgels - 200 mg total CoQ10
2 softgels - 200 mg total CoQ10
2 capsules - 200 mg total CoQ10
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.
Time frame: 72 hours
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.
Time frame: 72 hours
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.
Time frame: 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.
Time frame: 72 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2021 to primary completion in May 2021, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Nutrition Institute, Slovenia