None listed
Conditions
Interventions
Intervention1: Co-Enzyme Q10: 120 mg in 4 mL Nano Emulsion (liquid) Oral dose Single treatment
Control Intervention1: Co-Enzyme Q10: 120 mg capsule Oral dose Single treatment
Sponsors
Dr Tobias Meller
Eligibility
Inclusion criteria
Inclusion criteria: Normal healthy adult human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2 Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in. Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance. Healthy as documented by the medical history physical examination (including but may not be limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system) and vital sign assessments. Generally healthy as documented by 12-lead electrocardiogram (ECG) X-Ray and clinical laboratory assessments. Non-smokers or ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months. Willing to consume vegetarian diet. Willing to comply with all requirements of this study protocol as well as instructed by the study personnel. Generally healthy as documented by gynaecological examination and breast examination (for female subjects ââ?¬â?? study period). Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH. Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of study period. If subject is female; currently not pregnant, not lactating, or not attempting to become pregnant for 4 weeks before the screening visit, throughout the duration of the study and 3 weeks after the subjectââ?¬•s last study-related visit (for eligible subjects only, if applicable), has a negative pregnancy test. If male and sexually active the subject is willing to commit to 2 acceptable methods of birth control for the duration of the study. 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.
Exclusion criteria
Exclusion criteria: Evidence of allergy or known hypersensitivity to Co-Enzyme Q10 or its inactive ingredients. History of intake of Co-Enzyme Q10 supplement. Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and pre-existing gallbladder disease. Any major illness in the last three months or any significant on-going chronic medical illness. Renal or liver impairment. Any disease or condition which might compromise the hemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system diabetes psychosis or any other body system. History of alcohol addiction or abuse. Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) cigarette, tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study. Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to check-in and throughout the entire study. Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study and any over the counter medicinal products, herbal medications within 07 days prior to check-in and throughout the study. Subjects who have taken an unusual diet, for whatever reason (e.g. low salt) for 48.00 hours prior to check-in and throughout the study. Subject who had participated in any other study within the 90 days of check-in. History of difficulty in swallowing. History of difficulty in accessibility of veins. Positive results for urine screen of drugs of abuse (Marijuana-THC, amphetamine-AMP, barbiturates-BAR, cocaine-COC, benzodiazepines-BZD and morphine-MOR) in urine prior to check-in of study period. Positive results for alcohol test prior to check-in of study period. Any blood donation / excess blood loss within 90 days of check-in. Use of hormone replacement therapy for a Period of 06 months prior to dosing. Female subjects demonstrating a positive pregnancy screen. Female subjects who are currently lactating. Females likely to become pregnant during conducting of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the Oral Bioavailability Study of Co-Enzyme Q10 (CoQ10) 120 mg in 4 mL Nano Emulsion (liquid) administered sublingually.Timepoint: 17 00.00, 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of a single dose administered in healthy human adult subjects under fed conditions.Timepoint: 17 00.00, 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours | — |
Countries
India
Contacts
Public ContactDr K Annamalai MBBS MBA MSc Psychology
Spinos Lifescience and Research Pvt Ltd
Outcome results
None listed