Clinical Study to Compare the Effect of an Oral Rehydration Solution on the Rate of Absorption of Functional Ingredients

Exclusion Criteria

• •Subjects who are participating in another Clinical Trial.
• •Subjects who faint during blood collection, or who have a phobia of needles, or a phobia of blood.
• •Subjects who have been diagnosed with any sleep disorder.
• •Subjects who are night shift workers.
• •Subjects who use tobacco or nicotine-containing products or devices within 1 year prior to the screening visit through the end of study.
• •Females who are pregnant or lactating (verbal confirmation only).
• •Subjects with history or presence of any clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine (e.g., insulin resistance, diabetes I or II), immunologic (e.g., arthritis), dermatologic, neurological, psychiatric disease or disorder (including anxiety or depression), or any uncontrolled medical illness which in the opinion of the Investigator would jeopardize the safety of the subject, interfere with study assessments, or impact the validity of the study results.
• •Subjects with history of any gastrointestinal surgery, gastrointestinal illness which in the opinion of the Investigator would affect the digestive and absorption processes of the body (i.e., Gastric bypass, Gastroenteritis, Irritable Bowel Syndrome, Celiac Disease).
• •Subjects with history of cancer (except localized skin cancer without metastases) within 5 years prior to the screening visit. Subjects who exhibit evidence of hepatic or renal dysfunction as evidenced by abnormal ALT, AST or ALP level ≥2 times of the upper limit of normal range or abnormal serum creatinine level ≥ 2.0 mg/dl or other clinically significant laboratory value per Investigator discretion.
• •Subjects with positive laboratory result for HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody.
• •Subjects with history of substance or alcohol abuse within 1 year prior to the screening visit (whereas had to be seen in an Emergency Room, Urgent Care or was hospitalized for care of such).
• •Subjects who received any investigational product within 30 days prior to the screening visit.
• •Subjects with recent or current medical condition that may significantly affect the PK analysis, compromise the safety of the subject, or impact the validity of the study results in the opinion of the Investigator.
• •Subjects who have a known or suspected allergy or sensitivity to study products or any of its ingredient(s) or to any comparable products in the opinion of the Investigator (e.g., caffeine, vitamin C, L-theanine (including green tea), melatonin etc.)
• •Subjects who use any prescription or over-the-counter (OTC) medication, vitamins, herbal products, antacids, mineral supplements and dietary supplements, within 4 weeks prior to the 1st study period and through the end of study (with the exception of acetaminophen).
• •Chronic use of NSAIDs (e.g., Ibuprofen, Advil), or use of NSAIDs at one-week prior to each study Visit.
• •Subjects being treated with any known enzyme-altering drugs such as barbiturates, glucocorticoids, macrolides, antidepressants, neuroleptics, imidazole's, fluoroquinolones, calcium channel blockers, proton pump inhibitors, or H2-receptor antagonists, etc., within 30 days prior to screening or through the end of study.
• •Subjects who (for whatever reason) have been on a self-restricted diet, controlled diet or special therapeutic diet, or who have had substantial changes in eating habits within 30 days prior to PK Test Period 1 or through the end of study.
• •Subjects with difficulty fasting or consuming standard meals or snacks.
• •Subjects with a proclivity to lose consciousness (faint / pass-out), feel weak, feel dizzy, or feel nauseous.
• •Donation of blood (\>300 ml) within 30 days or plasma within 7 days prior to PK Test Period 1 or through the end of study. Intolerance to venipuncture and intravenous cannulation.
• •Subjects who are currently taking biotin supplements or have stopped taking Biotin within the last month to pre-study screening.
• •Subjects who are currently taking or have taken within the last month before pre-study screening any form of psychoactive, or psychotropic drugs, including cannabinoids, CBD oils or THC.
• •Subjects who are transgender or receiving any form of therapeutic intervention to instigate or maintain gender changes, or performance enhancing drugs, e.g., hormonal injections, steroid injections.
• •Subjects who have taken L-theanine, melatonin, valerian root, GABA, tart cherry, amla, ashwagandha, rhodolia, ginseng, shatavari less than 14 days of pre-screening visit.
• •Subjects whose veins have been deemed unsuitable for the study during screening checks.