Stage 1 Single Dose Study A Randomized, Open Label, Balanced, four Treatments, single period, Single Dose and , parallel, comparative bioavailability Study of Nanomicelle formulation of CoQ10, Test Product T UBISOL Q10 20mg per mL Oral liquid 5mL with reference product R1 Qunol Ultra CoQ10 100mg Soft gel Capsule, reference product R2 Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and reference product R3 CPM Coenzyme Q10 25mg per ml oil for intramuscular administration 4 mL in Healthy, Adult, Human Subjects under non fasting Condition.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To demonstrate the comparative bioavailability Study between Test
研究概览
简要总结
Ubiquinol (CoQ10) is safe as a dietary supplement and indicated for heart failure, high blood pressure, gum disease, Parkinson disease, blood infections, certain diseases of the muscles, fibromyalgia, diabetes and HIV infection.
This present study will be conducted in compliance with the protocol approved by the Ethics Committee (EC) and according to Good Clinical Practice (GCP) standards. The primary objective of the study to evaluate and demonstrate single dose, comparative Bioavailability of test product; UBISOL- Q10® (20mg/mL) Oral liquid with the already available marketed product (R1):Qunol Ultra CoQ10 100mg Soft gel Capsule, (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) in healthy adult human subjects under non fasting condition.
Also To demonstrate the Multiple Dose, parallel, comparative steady
state bioavailability between Test Product (T1): 5 mL of UBISOL-Q10 (20mg/mL) with Test product (T2): 10 mL of UBISOL-Q10 (20mg/mL), Test product (T3): 20 mL of UBISOL-Q10 (20mg/mL) and Test product (T4): 25 mL of UBISOL-Q10 (20mg/mL) in healthy, adult, human subjects under non fasting condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy human subjects (Male and female), age in the range of 18-50 years both inclusive.
- •Body Mass Index between 18.5-29.9 Kg / m2 extremes included with a minimum of 48 kg weight.
- •Subjects with normal findings as determined by baseline history, physical examination and vital sign examination.
- •Subjects with clinically acceptable findings as determined by haemogram, Lipid Profile test, biochemistry, urinalysis, urine pregnancy test (for female subjects only) and 12 lead ECG.
- •Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until the last blood sample collection in study period and adherence to all study restrictions.
- •Willing to accurately fill a food diary during the duration of the study.
- •No history of significant alcoholism.
- •No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 06 months.
- •Non-smokers as evident from the history obtained.
- •Willing to provide written informed consent to participate in the study (In the case of illiterate, informed consent will be taken in presence of impartial witness).
- •Subjects willing to use acceptable birth control measures (abstinence, barrier methods like condom with spermicidal jelly etc.) throughout the study duration.
- •Healthy individuals, not taking prescription medications for at least a month prior to the start of enrolment for the study and during the study.
- •Willing to provide written informed consent to participate in the study (In the case of illerate, informed consent will be taken in presence of impartial witness).
- •Fasting the night before enrolment for at least 12.00 hrs.
排除标准
- •Known history of hypersensitivity to Jamieson CoQ10 or related drugs or any of the excipients.
- •Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days prior to dosing day.
- •Subjects who have taken prescription medications or over the counter products (including vitamins and minerals) within 14 days prior to administration of IP.
- •Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- •History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- •Participation in a clinical drug study or Bioavailability study within 90 days prior to Period- I dosing of the present study.
- •Not eligible as per Online Volunteer Information System (OVIS).
- •Volunteer who have donated blood or experienced loss of blood of up to 150 ml within 30 days or in between 150 ml to 250 ml within 60 days or more than 250 ml within 90 days (exclude blood loss for screening) prior to first dose of study.
- •History of malignancy or other serious diseases.
- •Subjects with positive result of HIV tests or HBsAg or Hepatitis C tests during screening.
- •Found positive in breath alcohol test and/or urine test for drug abuse.
- •History of problems in swallowing of tablet/capsule.
- •Any contraindication to blood sampling.
- •Male human subjects not willing to use birth control measures, from the period-I dosing until the completion of the study.
- •Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
- •Subjects with a history of taking Statin drugs that will affect Q10 level.
- •Subjects taking supplements of Q10 for at least four weeks prior to the check in or other vitamin supplements for at least two weeks prior to check in.
- •Use of hormonal contraceptives either oral or implants.
- •Taking any prescribed medication including coumadin warfarin within 4 weeks of enrolment into the study.
- •Taking any food supplements especially supplements containing Coenzyme Q10 within 4 weeks of enrolment into the study, except vitamin D and calcium.
- •Regular drug and/or alcohol abuse; using any form of nicotine or tobacco, mental incapacity that may prevent adequate understanding or cooperation of the participation in the study as assessed by the study screener.
- •Female subjects found positive serum Beta- hCG (Human Chorionic Gonadotropin) test.
- •Lactating women (currently breast feeding).
- •Female subjects not confirming to using birth control measures, from the date of screeninguntil the completion of the study.
结局指标
主要结局
To demonstrate the comparative bioavailability Study between Test
时间窗: Collection of the blood samples before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible. | For dosing day 02 to Dosing day 09 blood sample will be collected | through the fresh vein puncher | Product (T): UBISOL- Q10® (20mg/mL) Oral liquid (5mL) with reference product (R1): | Qunol Ultra CoQ10 100mg Soft gel Capsule, (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) in healthy, adult, human subjects under non fasting condition | before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible
Product (T): UBISOL- Q10® (20mg/mL) Oral liquid (5mL) with reference product (R1):
时间窗: Collection of the blood samples before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible. | For dosing day 02 to Dosing day 09 blood sample will be collected | through the fresh vein puncher | Product (T): UBISOL- Q10® (20mg/mL) Oral liquid (5mL) with reference product (R1): | Qunol Ultra CoQ10 100mg Soft gel Capsule, (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) in healthy, adult, human subjects under non fasting condition | before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible
Qunol Ultra CoQ10 100mg Soft gel Capsule, (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) in healthy, adult, human subjects under non fasting condition
时间窗: Collection of the blood samples before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible. | For dosing day 02 to Dosing day 09 blood sample will be collected | through the fresh vein puncher | Product (T): UBISOL- Q10® (20mg/mL) Oral liquid (5mL) with reference product (R1): | Qunol Ultra CoQ10 100mg Soft gel Capsule, (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) in healthy, adult, human subjects under non fasting condition | before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible
before the pre-dose (-02.00 hour)
时间窗: Collection of the blood samples before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible. | For dosing day 02 to Dosing day 09 blood sample will be collected | through the fresh vein puncher | Product (T): UBISOL- Q10® (20mg/mL) Oral liquid (5mL) with reference product (R1): | Qunol Ultra CoQ10 100mg Soft gel Capsule, (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) in healthy, adult, human subjects under non fasting condition | before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible
blood sample collection and keep up to 23.00 hrs post-dose (Dosing
时间窗: Collection of the blood samples before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible. | For dosing day 02 to Dosing day 09 blood sample will be collected | through the fresh vein puncher | Product (T): UBISOL- Q10® (20mg/mL) Oral liquid (5mL) with reference product (R1): | Qunol Ultra CoQ10 100mg Soft gel Capsule, (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) in healthy, adult, human subjects under non fasting condition | before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible
day 01 and dosing day 10) if possible
时间窗: Collection of the blood samples before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible. | For dosing day 02 to Dosing day 09 blood sample will be collected | through the fresh vein puncher | Product (T): UBISOL- Q10® (20mg/mL) Oral liquid (5mL) with reference product (R1): | Qunol Ultra CoQ10 100mg Soft gel Capsule, (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) in healthy, adult, human subjects under non fasting condition | before the pre-dose (-02.00 hour) | blood sample collection and keep up to 23.00 hrs post-dose (Dosing | day 01 and dosing day 10) if possible
次要结局
- To monitor the safety and tolerability of a single & multiple dose(of investigational medicinal products (IMPs).)
研究者
Viral Patel
Sycon Clinical Research Private Limited