NCT07255079已完成不适用
A Randomized, Blinded, Comparator Controlled, Cross-over Clinical Trial to Assess the Pharmacokinetic Profile of Three Coenzyme Q10 Formulations in Healthy Adults
3i Solutions1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年4月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in the bioavailability of three Coenzyme Q10 (CoQ10) formulations as assessed by the incremental area-under-the-curve (AUC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Males and females 18 to 60 years of age, inclusive
- •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
- •Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- •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)
- •Double-barrier method
- •Intrauterine devices
- •Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- •Vasectomy of partner at least 6 months prior to screening
- •Abstinence and agrees to use contraception if planning on becoming sexually active during the study
- •Willingness to complete questionnaires and diaries associated with the study and complete all study requirements
- •Agrees to maintain current lifestyle (diet, physical activity, medications, supplements, and sleep) as much as possible within study specific requirements throughout the study
- •Provided voluntary, written, informed consent to participate in the study
- •Healthy as determined by medical history and laboratory results as assessed by the Qualified Investigator (QI)
排除标准
- •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.…)
- •Unstable metabolic disease or chronic diseases as assessed by the QI
- •Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- •Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- •Type I or Type II diabetes
- •Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- •History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- •Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- •Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- •Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- •Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- •Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- •Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- •Use of prescribed cannabinoid products
- •Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- •Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
- •Alcohol intake average of >2 standard drinks per day as assessed by the QI
- •Alcohol or drug abuse within the last 12 months
- •Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Sections 7.3.1 and 7.3.2)
- •Clinically significant abnormal laboratory results at screening as assessed by the QI
- •Significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to Visit 2 or a blood donation of more than 450 mL within 56 days prior to Visit 2
- •Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- •Individuals who are unable to give informed consent
- •Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
研究组 & 干预措施
VitaDry-CoQ10
Experimental
VitaDry CoQ10 contains 100 mg of CoQ10 per serving.
干预措施: VitaDry-Q10 (Dietary Supplement)
VitaSperse-CoQ10
Experimental
VitaSperse-CoQ10 contains 50 mg of CoQ10 per serving.
干预措施: VitaSperse-Q10 (Dietary Supplement)
CoQ10
Experimental
CoQ10 contains 50 mg of CoQ10 mg per serving.
干预措施: Coenzyme Q10 (Dietary Supplement)
结局指标
主要结局
Difference in the bioavailability of three Coenzyme Q10 (CoQ10) formulations as assessed by the incremental area-under-the-curve (AUC)
时间窗: 0 to 72 hours post dose
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)
次要结局
- Difference in incremental AUC between three CoQ10 formulations(0 hours to infinity post dose)
- Difference in AUC between three CoQ10 formulations(0 hours to 72 hours post dose)
- Difference in Maximum concentration (Cmax) between three CoQ10 formulations(0 hours to Cmax post dose)
- Difference in time to peak maximum concentration (tmax) between three CoQ10 formulations(0 hours to tmax post dose)
- Difference in half-life (t1/2) between three CoQ10 formulations(0 hours to tmax post dose)
研究者
研究点 (1)
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