Welcome!
We know you might have questions about our research study.
Welcome to 3i Solutions CoQ10 clinical study. This study is to assess the pharmacokinetic profile of three Coenzyme Q10 formulations in healthy adults
Here’s what you need to know about participating. This page provides a summary. For full details about your rights, potential risks, and study procedures, please refer to the complete Participant Information and Consent Form.
The following steps are required to proceed:
In this video, you will find the purpose of this study, the study design, risks and benefits and what is expected from the participant and if you decide to participate. After listening to this recording, please read the informed consent and assent forms and the Frequently Asked Questions.
CoQ10 PK Study Introduction Video
2.Please Review the ICF Form here.
Please review the Informed Consent Form. You do not need to sign this copy but will be required to sign an electronic copy when you decide to join the study and before screening can begin.
3. Frequently Asked Questions
What is the purpose of this clinical study?
- This clinical trial is A randomized, blinded, comparator controlled, cross-over clinical trial to assess the pharmacokinetic profile of three Coenzyme Q10 formulations in healthy adults
- The purpose of this study is to compare how the body absorbs two investigational Coenzyme Q10 (CoQ10) formulations in comparison to a standard CoQ10 supplement in healthy adults. Results from this study will help determine whether the investigational products are absorbed differently and may inform future research on their potential use. This study is not designed to diagnose, treat, or prevent any disease.
What is the study product? What is in it?
- If you are enrolled into the study, you will receive the investigational products and the comparator, but at separate times.
Active Ingredient | Quantity and Acute Dose |
CoQ10 Product 1 | 100 mg of CoQ10 |
CoQ10 Product 2 | 100 mg of CoQ10 |
CoQ10 Product 3 | 100 mg of CoQ10 |
Non-medicinal ingredients:
- CoQ10 Product 1: Water, Capric/Capyric triglycerides, Natural flavors, Monk fruit juice concentrate, Sunflower lecithin, Polyglycerol esters fatty acids, Citric acid, Potassium sorbate, Alpha-tocopherol
- CoQ10 Product 2: Veggie Capsules, Modified food starch , Calcium phosphate dibasic, Capric/Caprylic triglycerides, Sunflower lecithin, Silicon dioxide, Polyglycerol esters fatty acids, Magnesium Stearate, Citric acid, Potassium sorbate, Alpha-tocopherol
- CoQ10 Product 3: Veggie Capsules, Calcium Phosphate dibasic, Silicon dioxide, Magnesium stearate
Are there any side effects?
It is possible that you could have problems or side effects from the study product that nobody knows about yet. There may be unknown risks with taking the study product. Potential side-effects of taking the study product may include:
- Nausea
- Stomach upset/ abdominal discomfort
- Diarrhea or loose stools
- Heartburn
- Reduced appetite
- Mild/Transient headaches
- Dizziness
- Insomnia or difficulty in sleeping (in a minority of individuals)
Please consult with your healthcare provider if your migraine increases by frequency or is associated with other symptoms like nausea or vomiting.
How/when will I receive the product?
Study product is provided in clinic during your visits at no cost to yourself
How often and when do I need to take study product?
- You will take one dose of study product at the clinic on Day 1 of each of the three study periods. A study staff member will administer the dose and confirm that it has been taken.
- Depending on which study product you are given, you will take the dose as follows:
- Liquid Study Product: You will be given 5 mL of the liquid study product using an oral syringe and will then drink a cup of water.
- Capsule Study Product: You will take 2 capsules (50 mg each) for a total dose of 100 mg, with a cup of water.
- Immediately after taking the study product, you will be provided with a standardized meal and will be required to eat the entire meal. You will be asked to finish this meal within 20 minutes.
- To reduce the effects of posture and physical activity on digestion and blood flow, you will be asked to stay seated upright as much as possible for the first 2 hours.
- You will also receive standardized meals 4 and 8 hours after receiving the study product. You will be asked to eat the entire meals and to finish them within 30 minutes.
How/ when can I find out if I got the investigational product or the comparator?
Crossover means you will receive all three study products, but at separate times. This study is blinded, meaning yourself, the clinic staff, and the researchers analyzing the data will not know if you received a CoQ10 product or, one of the comparators.
If you qualify for this study, you will be assigned to one of the groups by chance, like flipping a coin, this helps prevent bias in data collection, reporting and interpreting results. Once all participants have exited the clinical study, and the final report is written, an e-mail will be sent to you revealing which product you have received during your participation.
How long will the study last?
Once you have been enrolled into the study, your participation will continue for approximately 32 days
What does randomization mean?
Randomized means that you will be assigned by chance, like flipping a coin, which determines the order in which you receive the study products.
Do I have to come into the clinic for any assessments?
Yes, after the screening period, there are 12 clinic visits over a 32 day period
Who do I contact if I have questions or concerns?
You can reach the study staff at KGK Science anytime:
Phone: 519-438-9374
Email: clinic@kgkscience.com
Address: 275 Dundas St, Suite G02, London, ON N6B 3L1
Please contact us if you:
- Experience a medical issue
- Think you’ve had a side effect
- Wish to withdraw from the study
- Have questions about test results or study procedures
What is the compensation for participating?
For your time and participation in the study, you will be compensated a total of $1500 if you complete the entire study and all associated requirements.
How and when will I receive my compensation for participating?
- After completion of the study, you will receive your compensation on a ClinCard. You will receive the Clincard at your final visit.
- Your ClinCard is a prepaid credit card that can be used anywhere that accepts Mastercard, or the funds can be withdrawn from an ATM (ATM fees apply). Processing times may apply before funds become available on your ClinCard.
Will my personal information be kept private?
Yes, absolutely. All your personal and medical information will be kept confidential to the extent required by law. You will not be identified in any publication that may result from the study.
Your participation is completely voluntary.
Take your time, ask questions, and only join the study if you feel comfortable.
Thank you for your interest in our study! If anything is unclear or you need more information, don’t hesitate to reach out.