None listed
Conditions
Interventions
Intervention1: Beta alanine complex Plus liquid containing 400 mg of beta alanine: In morning, single dose of 40ml to be taken with water in fasting condition.
Control Intervention1: Reference product
Sponsors
Natural Alternatives International
Academy of Material Research
MOLECULES BIOLABS PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy, adult, male and female human subjects of age between 50-65 years with a body mass index (BMI) range between 18.50 kg per m2 to 24.99 kg per m2 . 2. Subject agrees avoid beta-alanine containing medications and dietary supplements from screening until last visit. 3. Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit 4. Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 29 days of check in. 5. Subjects whose screening laboratory values are within normal limits or considered by the physician or principal investigator to be of no clinical significance. 6. 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 systems) and vital sign assessments. 7. Generally healthy as documented by clinical laboratory assessments. 8. Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months. 9. Willing to consume ova-lacto vegetarian diet. 10. Willing to comply to all requirements of this study protocol as well as instructed by the study personnel 11. Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH and LH. 12. Generally healthy as documented by gynecological examination and breast examination (for female subjects during check-in only).
Exclusion criteria
Exclusion criteria: Evidence or history of clinically significant medical conditions. 2. Evidence of allergy or known hypersensitivity to beta alanine or other related drugs or other related drugs. 3. Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease. Any major illness in the last three months or any significant ongoing chronic medical illness. 4. Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system. 5. History of alcohol addiction or abuse. 6. Malabsorption syndrome that affects Beta alanine metabolism. 7. Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than100 per min ventricular rate. 8. Gastrointestinal bleeding in past three months. 9. Uncontrolled diabetes mellitus. 10. Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness. 11. Psychopathic disorder, lack of cooperation. 12. Chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months) 13. Taking more than 100 mg beta-alanine daily within 2 weeks to screening. 14. Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study 15. Consumption of grapefruit and its juice and poppy containing foods for at least 72.00 hours prior to check-in and throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the oral bioavailability of investigational product (beta-alanine complex Plus liquid (400 mg)), reference product I Beta-alanine complex liquid (400 mg)) and reference product II (Conventional beta-alanine liquid (400 mg)) in healthy, adult, Human participants under fasting conditions. Timepoint: baseline and End of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events & to ensure the safety of the subjects. Timepoint: Baseline & end of study. | — |
Countries
India
Contacts
Public ContactShalini Dayananda
Unitree Health Care Diagnostics
Outcome results
None listed