None listed
Conditions
Interventions
Intervention1: Test product (T): UBISOL- Q10 (20mg/mL) Oral liquid (5mL): A single oral dose of 5 mL, Total duration-Single dose
Control Intervention1: Reference product (R1): Qunol Ultra CoQ10 100mg
Sponsors
Micillic Lda
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the comparative bioavailability Study between Test 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 possibleTimepoint: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of a single & multiple dose of investigational medicinal products (IMPs). Timepoint: Pre dose-Well-being assessment, measurement of blood pressure,oral temperature and pulse rate (within 03.00 hour prior to dosing) on day 01 to day 10 Post dose-Well-being assessment, blood pressure and pulse rate (on all the dosing days). Post-dose vitals at 03.00, 06.00, and 13.00 hrs. 40 minutes of scheduled time will be measured on all the dosing day 1 to day 10. Checkout-Well-being assessment, physical examination and vital signs measurement (blood pressure, pulse rate, and oral temperature). Physical examination and vital examination can be started approximately 03.00 hours prior to the scheduled time in study period. | — |
Countries
India
Contacts
Public ContactViral Patel
Principal Investigator
Outcome results
None listed