None listed
Conditions
Interventions
Intervention1: Creatine Nano 400: Dissolve entire 3.1 g in 240 mL water mix for 30 45 seconds until dispersed. Add remaining 60 mL water to rinse container, participant to consume entire contents.
Con
Sponsors
BeastLife RAK Fitness Consumer Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able to read and understand and ready to provide written informed consent. 2. Healthy adult male human beings within the age of 18-45 years. Both inclusive 3. Having A Body Mass Index BMI in the range 18.50 27.00 kgm2 and weight at least 50 kg. Both inclusive. 4. Must be of normal health as determined by medical history and physical examination ECG and laboratory tests performed within 28 days prior to the commencement of the study. 5. Chest Xray is normal or considered by the physician Principal Investigator to be of no clinical significance. 6. Screening laboratory values are within normal limits or considered by the physician Principal Investigator to be of no clinical significance. 7. Participants should not be engaged in intensive resistance or weight training programs during the study period. 8. Willing and able to comply with study procedures and assessments.
Exclusion criteria
Exclusion criteria: 1. Participant with known hypersensitivity or idiosyncratic reaction or intolerance to Creatine or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions to any drugs. 2. Participants with a history of known food allergy. 3. Participant having a history of drug abuse or alcoholism i.e., alcohol consumption 2 units day or 10 units week (one unit of alcohol 50 ml spirit or 200 ml wine or 500ml beer 4. Participant having a history of smoking Smoker to be excluded. 5. Participant having a history of allergy to heparin preservatives dyes. 6. Intake or administered any drugs or over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study drug administration in the study. 7. Participants with or prior history of clinically significant Cardiovascular pulmonary hepatic renal hematological gastrointestinal endocrine immunologic dermatologic musculoskeletal neurological or psychiatric disease 8. Participants who participated in any other clinical trial requiring repeated blood sampling or a blood donation program or blood loss of more than 350 ml in the past three months approx 90 days This 350 mL includes the total blood loss that will occur during the study. 9. Participant who has difficulty with donating blood. 10. Positive Breath Alcohol Analysis or Urine Drug Screen UDS before admission of the study. 11. Radial Pulse rate less than 60 min or above 100 min. 12. Clinically significant abnormal lab values abnormal ECG and Chest XRay. 13. Presence of disease markers of HIV 1 or 2 Hepatitis B or C viruses and syphilis. 14. Suffered with any illness or who have been hospitalized within the last 4 weeks preceding the start of the study. 15. History or presence of significant gastrointestinal liver or kidney disease or any condition known to interfere with the absorption distribution metabolism or excretion of drugs or known to potentiate or predispose to undesired effects. 16. Presence of active peptic ulceration or a history of peptic ulceration. 17. History of Myocardial Infarction, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic- Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage. 18. History of known food allergy. 19. History of smoking or tobacco consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the bioavailability of the Test formulation of creatine with the Reference formulation following single oral administration under fasting condition.Timepoint: pre dose (00.00 hour) and at 00.50, 01.00, 01.50, 02.00, 04.00 and 06.00 hours post dose in both period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of both formulations in healthy adult participantsTimepoint: pre-dose (00.00 hour) and at 00.50, 01.00, 01.50, 02.00, 04.00 and 06.00 hours post dose in both period. | — |
Countries
India
Contacts
Public ContactMr Manoj Karwa
BeastLife RAK Fitness Consumer Pvt Ltd
Outcome results
None listed