None listed
Conditions
Interventions
Intervention1: NovaSOL® Q 100 mg Capsules: Subjects will be housed in the clinical facility for at least -36.00
hours pre-dose to 72.00 hours post-dose. A washout period of at least 14 days will
be
Sponsors
Aquanova AG
Eligibility
Inclusion criteria
Inclusion criteria: Normal, healthy, adult, human subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 30.00 kg/m2 (according to the formula BMI = weight (kg) / [height (m)]2). 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 are 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 not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal, and central nervous system) and vital sign assessments. Generally healthy, as documented by a 12-lead electrocardiogram (ECG), Chest X-Ray and clinical laboratory assessments. Willing to consume Ovo lacto-vegetarian diet. Willing to comply with all requirements of this study protocol as well as instructions from the study personnel. Non- smokers. Generally healthy, as documented by gynaecological examination and breast examination for female subjects – period I only. Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to the initiation of the study and a negative urine pregnancy test prior to check-in for each period. If the 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 subjects last study related visit (for eligible subjects only if applicable) has a negative serum pregnancy test and is of non childbearing potential defined as more than one year post-menopausal (no menstrual period for at least 12 consecutive months without any other medical cause) Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or is of childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide) intrauterine device (IUD) with a low failure rate of less than one percent per year or is of childbearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active.
Exclusion criteria
Exclusion criteria: Evidence of allergy or known hypersensitivity to Coenzyme Q10 or its inactive ingredients. Subjects with hepatic encephalopathy, cholestasis, myasthenia preexisting liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease. Any major illness in the last three months or any significant ongoing chronic medical illness. Renal or liver impairment. Any disease or condition that might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, or any other body system, including presence of Diabetes Mellitus and Psychosis. History of alcohol addiction or abuse. Consumption of caffeine and or xanthine containing products (i.e., coffee, tea, chocolate, caffeine-containing sodas, colas, etc.), cigarettes, and tobacco containing products for at least 48.00 hours prior to check-in and throughout the entire study. Consumption of alcohol and its products, and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study. Grapefruits and its products should not be taken for 14 days prior to trial. 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 study check-in and throughout the study. Subjects who have taken any unusual diet, for whatever reason (e.g. low salt) for 48.00 hours prior to dosing 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. Absisitence from OTC drugs for past 06 months. 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 each period. Positive results for alcohol test prior to check-in of each period. Any blood donation or excess blood loss within 90 days of check in. Ingestion of any hormonal agent at any time within 14 days prior to the start of the study 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 are likely to become pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the Oral Bioavailability of NovaSOL® Q 100 mg capsules, Kaneka Ubiquinol® 100 mg Capsules versus Native Coenzyme Q10 100 mg Capsules in healthy, Adult Human Subjects Under Fasting Conditions.Timepoint: 42 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of test product comparing with the reference product in healthy, adult, human subjects under Fasting conditions.Timepoint: 42 Days | — |
Countries
India
Contacts
Public ContactDivya C
BioAgile Therapeutics Private Limited
Outcome results
None listed