A Clinical Trial to Assess the Pharmacokinetic Profile of Three Coenzyme Q10 Formulations in Healthy Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
Sponsor3i Solutions
About this trial
The goal of this clinical trial is to assess the pharmacokinetic profile of three Coenzyme Q10 formulations in healthy adults. The main question it aims to answer is:
What is the difference in the bioavailability of three Coenzyme Q10 (CoQ10) formulations as assessed by the incremental area-under-the-curve (AUC) from time 0 to the last measured timepoint (AUC0-72hr)?
Participants will be asked to consume three formulations of CoQ10 and will be evaluated for CoQ10 levels in blood, over a 71-day period.
Eligibility criteria
Qualifiers
Males and females ≥ 18 years of age
BMI between 18.5 to 29.9 Kg/m3, inclusive
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Disqualifiers
Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Poor venous access, as assessed by the QI
Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational products or comparator ingredients or inability to consume the standardized meals
Following a specific diet (e.g. vegetarian, carnivore, paleo, vegan, etc.…)
Trial design
Treatments tested in this trial
- VitaDry-Q10
- VitaSperse-Q10
- Coenzyme Q10
Treatment groups
20 Participants
are divided into 3 treatment groupsSponsors and collaborators
3i Solutions
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov