To Evaluate Oral Bioavailability Efficacy of Co Enzyme Q10 100mg in Healthy Human Adult Subjects
- Registration Number
- CTRI/2022/10/046730
- Lead Sponsor
- Doctors Best Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subjects must fulfill all of the following criteria to be considered for inclusion in this study:
a)Healthy human subjects between 18 to 45 years of age (both inclusive).
b)Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg/height in m2.
c)Have no clinically significant abnormal findings as judged by investigators during screening within 21 days prior to administration of first dose of study drug, medical history and examination, laboratory evaluations and 12-lead ECG recordings.
d)Able to comply with the study procedures, in the opinion of the PI/CI.
e)Able to give written consent for participation in the study.
f)If the subject is sexually active and is willing to commit to 2 acceptable methods of birth control for the duration of the study.
g)The subject and their partners are willing to use 2 types of contraception, one of which is a barrier method, such as the use of a condom throughout the study.
a)Known hypersensitivity or idiosyncratic reaction to CoQ10 and its active ingredients.
b)Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular immunological, dermatological, gastrointestinal or any other body system.
c)Ingestion of a medicine at any time within 14 days before dosing. In any such case subject selection will be at the discretion of the PI/CI and medicine taken will be recorded.
d)Any history or presence of asthma (including aspirin induced asthma) or NSAID induced urticaria.
e)A recent history of alcoholism (120 mL or more per day) and consumption of alcohol within 24 hours prior to receiving the study drug.
f)Smokers, who smoke 9 or more cigarettes / day or inability to abstain during the study.
g)Habituated to drinking tea or coffee (more than 5 cups/day) or inability to abstain during the study.
h)Habituated to tobacco/tobacco containing products /Gutkha (more than 10 gm/day) or inability to abstain during the study
i)A positive result for hepatitis B & C, HIV antibody and syphilis (VDRL) tests.
j)Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scan.
k)Recent history of gastrointestinal fluid loss viz., vomiting, diarrhea.
l)History of difficulty with donating blood.
m)Donation of blood/ Plasma (1 unit: 350 mL / 450 mL) within 90 days prior to receiving the first dose of the study drug.
n)The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study drug.
o)Eligible subjects unwilling to employ appropriate contraceptive measures to ensure that his partner will not get pregnant during the study.
p)An unusual diet (e.g., low salt), for any medical reason or non-medical reason for three weeks prior to receiving the study drug and throughout the subjectâ??s participation in the study. In any such case subject selection will be at the discretion of the PI/CI.
q)Subjects having any deformity that will affect venous access for cannulation.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the Oral Bioavailability of 40% Co-Enzyme Q10 (CoQ10) 100 mg Veggie Capsule (2 Veggie Capsules) (T1) Manufactured for Doctorâ??s Best, Inc. USA, 30% Co-Enzyme Q10 (CoQ10) 200 mg Soft-gel Capsule (T2) Manufactured for Doctorâ??s Best, Inc. USA, with Co-Enzyme Q10 (CoQ10) 200 mg Veggie Capsule (R1) Manufactured for Doctors best. Inc, USA, Co-Enzyme Q10 (CoQ10) 200 mg Veggie Soft-gel Capsule (R2) Manufactured for Doctors best. Inc, USA, QUNOL Co-Enzyme Q10 (CoQ10) 100 mg Soft-gel Capsule (2 Soft-gel Capsules) (R3) Manufactured for Quten Research Institute, LLC, In Healthy, Adult Human Subjects Under Fed Conditions.Timepoint: 6 Days
- Secondary Outcome Measures
Name Time Method To monitor the safety and tolerability of a single dose administered in healthy human adult subjects under fed conditions.Timepoint: 6 Days