None listed
Conditions
Interventions
Intervention1: MuscleBlaze Creatine Monohydrate (CreAMP)TM: Each subject will be dosed with either Treatment A (MuscleBlaze Creatine Monohydrate (CreAMP)TM 3.1 gm) or Treatment B (Regular Creatine Mon
Sponsors
Bright Lifecare Pvt. Ltd. (Healthkart)
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 50 years old, both inclusive. 2) Gender: Male 3) BMI: 18.5 to 25.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 25.04 rounds down to 25.0, while 18.45 rounds up to 18.5). 4) Volunteer weighing = 50 Kg. 5) Able to communicate effectively with study personnel. 6) Able to read & understand informed consent document and give written informed consent to participate in the study. 7) Willing to provide written informed consent to participate and complete the study. 8) All volunteers must be judged by the principal or Co-investigator or physician as normal and healthy during a pre-study safety assessment done within 28 days of the first dose of study medication which will include: a) A physical examination (clinical examination) with no clinically significant finding. b) Results within normal limits or clinically non-significant for the following tests: Hematology Hemoglobin, Total RBC count, Total WBC count, Platelet count Blood indices: HCT Differential leukocyte count: Neutrophils, Lymphocytes, Eosinophils, Monocytes, Basophils Biochemistry BUN, Serum creatinine, Random glucose, SGPT, SGOT, Alkaline phosphatase, Bilirubin-total, Uric acid Urinalysis Color, quantity, specific gravity, appearance, sugar (glucose), ketones, reaction, albumin, bilirubin, and urobilinogen Immunological Tests HIV-I & II HBsAg Syphilis (RPR/VDRL) Anti HCV • Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion. • All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.
Exclusion criteria
Exclusion criteria: 1) Subject with known hypersensitivity allergic response or idiosyncratic reaction or intolerance to Creatine Monohydrate or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions to any drugs. 2) Current use of any performance enhancing substances or supplements within 7 days prior to dosing (excluding the study supplements). 3) Subjects with a history of known food allergy. 4) Subject having a history of drug abuse or alcoholism i.e. alcohol consumption more than 2 units per day or 10 units per week (one unit of alcohol 50 ml spirit or 200 ml wine or 500ml beer). 5) Subject 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) Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 8) Subjects 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) Subject who has difficulty with donating blood. 10) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording]. 11) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, renal, hepatic, respiratory, central nervous system or any other body system. 12) History or presence of bronchial asthma. 13) Use of any hormone replacement therapy within 3 months prior to the first dose of study medication. 14) Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication. 15) Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication 16) Individuals who have a history of smoking or currently use will be excluded from participation in the trial. 17) A positive hepatitis screen (includes subtypes B and C). 18) A positive test result for HIV antibody. 19) Volunteers who have received a known investigational drug within seven elimination half life of the administered drug prior to the first dose of study medication. 20) Volunteers who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or more than 200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater. 21) History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption. 22) Intolerance to venipuncture 23) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or Co-investigator, could contraindicate the volunteer’s participation in this study. 24) Institutionalized volunteers. 25) Use of any OTC products, vitamin, and herbal products, etc., within 7 days prior to the first dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the comparative bioavailability of Muscle Blaze Creatine Monohydrate (CreAMP) as compared to regular Creatine Monohydrate (micronized).Timepoint: 00.00 (pre-dose) and at 00.50, 01.00, 01.50, 02.00, 03.00, 04.00 and 06.00 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety & tolerability of the subject to MuscleBlaze Creatine Monohydrate (CreAMP).Timepoint: 00.00 (pre-dose) & at 00.50, 01.00, 01.50, 02.00, 03.00, 04.00 & 06.00 hours post dose | — |
Countries
India
Contacts
Public ContactPurushotam
Auriga Research Pvt Ltd
Outcome results
None listed