None listed
Conditions
Interventions
Intervention1: Nutrabay BioAbsorb Whey: Nutrabay BioAbsorb Whey (36 g powder) will be administered orally with 240 ? 2 mL of water in both periods, with a washout period of 7 days between them.
Contro
Sponsors
Nutrabay Retail Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Normal healthy adult human subject (Male and non-pregnant, non lactating female) aged between of 18 to 45 years. 2. Body weight not less than 50 kg for males and not less than 45 kg in case of females. 3. Normal BMI 18.50 to 24.99 kg per m2 (both inclusive) 4. Willingness to provide written Informed Consent to participate in the study. 5. Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by ethics committee. 6. Volunteer is able to communicate well with the investigator. 7. Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidence by written informed consent. 8. Subject must be in good health as determined by medical history, vital signs (blood pressure, body temperature, pulse rate, respiratory rate) and physical examination or showing no clinically significant abnormalities in the opinion of Principal or Clinical Investigator or designated physicians. 9. Normal or clinically non significant result of 12 lead ECG of the subjects. 10. Subject having clinical laboratory tests (Biochemistry, Hematology, and Urinalysis and Serology) results within normal reference range or evaluated as non-clinically significant by the investigator or physician. 11. Subject found negative in Breath alcohol test. 12. Subjects that can provide adequate evidence of their identity. 13. Ability to fast for at least 10.00 hours and consume standard meal. 14. Volunteers is non alcoholic and non smoker. 15. The subject willing to abstain from food and drinks, which may interact with circulatory, gastrointestinal, hepatic or renal function (e.g. alcoholic drinks or certain fruit juices such as grapefruit juice) for 72.00 hours prior to the check in of period I to throughout the study. 16. Ability and willingness to abstain from methyl xanthine-containing beverages or food (coffee, tea, coke, chocolate, power drinks) and grapefruit juice from 72.00 hrs. Prior to admission of period I to throughout the study. 17. A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine). 18. Subjects willing to not participate in any clinical research study and or blood donations till 180 days after completion of the study and during the study. 19. Female subjects: ? Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or Hysterectomy has been performed on the subject) or ? Female of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams; jellies, diaphragm, and intrauterine device (IUD) or abstinence. ? Female of childbearing potential must have a negative urine pregnancy test performed within 07 days prior to initiation of the study. ? Female subject must have a negative hCG pregnancy test prior to check in of each period. 20. Male Participants: ? Male agreeing to use appropriate contraceptive measures like Double Barrier method (condom + diaphragm, condom or diaphragm + spermicidal gel or foam), and should not donate sperm etc. during study and 07 days after completion of study.
Exclusion criteria
Exclusion criteria: 1. History of Hypersensitivity or intolerance of Protein Supplement. 2. Difficulty in swallowing the powder. 3. Anemia with hemoglobin less than 8 g per dL 4. Body Temperature less than 95.0 ?F or above 98.6?F 5. Radial Pulse rate less than 60 per min or above 100 per min 6. Those with a past or existing history of the following diseases or chronic or severe illnesses, including but not limited to the cardiovascular system, digestive system, urogenital system, respiratory system, blood system, endocrine system, immune system, mental nervous system, skeletal system, etc., that researchers believe are still clinically significant; Especially for subjects with gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, and other diseases that affect Product absorption, distribution, metabolism, and excretion. 7. Ingestion of a medicine at any time within 14 days before dosing in Period I. In any such case subject selection will be at the discretion of the PI or CI and medicine taken will be recorded. 8. Any history or presence of asthma (including aspirin induced asthma) or NSAID induced urticarial. 9. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion. 10. History or presence of cancer. 11. History or presence of easy bruising or bleeding. 12. People with positive results of any test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody. 13. A recent history of alcoholism (120 mL or more per day) and consumption of alcohol within 24 hours prior to receiving study Product. 14. History or presence of significant smoking (09 or more than 09 cigarettes or beedis per day) or could not abstain from smoking during study 15. Maintenance therapy with any drug. 16. Incapable of understanding the informed consent information. (Poor mental development or impaired cerebral function). 17. Subjects who have participated in another clinical study in the past 03 months prior to commencement of this study. 18. Participation in a drug research study within 90 days of screening. 19. Difficulty with donating blood. 20. Donation of blood or Plasma (01 unit: 350 mL or 450 mL) within 90 days for male and female prior to receiving the first dose of study product. 21. Refuse to abstain from food for at least 10.00 hr. prior to product administration and for at least 04.00 hr. after product administration in each period. 22. Refuse to abstain from fluid for at least 01.00 hr. prior to product administration and until 01.00 hr. after product administration 23. Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study. 24. Subject consumed tobacco or tobacco containing products, pan or pan masala, gutkha, masala (containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study. 25. Subject consumed caffeine and or xanthine-containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine containing sodas, colas, etc.) and grape fruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study 26. Major illness during the 90 days before screening 27. Found positive in Urine scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the comparative bioavailability of test product as compare to control product (protein supplement) in healthy male subjects. This study is intended to compare the % enhancement of amino acid levels i.e. enhancement of bioavailability of protein.Timepoint: Predose 00.00 hours and Post dose 01.00, 02.00, 03.00 and 4.00 hrs in both study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the study subjects will also be monitored and evaluated.Timepoint: Sitting blood pressure, pulse rate, respiratory rate, and body surface temperature will be recorded at check-in and before check-out in each period. Measurements of blood pressure, pulse rate, and body surface temperature will be taken in sitting/supine position at pre-dose (0:00), and at 1 hrs, 3 hrs and during checkout (?40 minutes) post-dose. AE/SAE monitoring will be conducted throughout the study. | — |
Countries
India
Contacts
Public ContactMr Manoj Karwa
Nutrabay Retail Pvt. Ltd.
Outcome results
None listed