None listed
Conditions
Interventions
Intervention1: Pronocte protein powder: There are two periods in this study.
In one study period, study product Pronocte protein powder (equivalent to 50 gm of Glucose) will be orally administered wi
Sponsors
Azista Industries Pvt Ltd
Hetero Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: Normal healthy, adult subjects between 18-45 years of age, who voluntarily give their consent to participate in this trial.
Exclusion criteria
Exclusion criteria: 1. History or presence of significant: - Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. - Alcohol dependence, alcohol abuse or drug abuse within the past one year. - Moderate to heavy smoking ( >10 cigarettes/day) or consumption of tobacco products. - Asthma, urticaria or other allergic type reactions after taking any medication. 2. Subjects who, through completion of the study, would have donated in excess of 500 ml of blood in 60 days or 450 ml in 10 week period or more than 900 ml of blood in 20 week period. 3. Subjects who have participated in another clinical trial within 60 days of study start. 4. Subjects who have (1) a Systolic blood pressure less than 90 mm of Hg and higher than 150 mm of Hg (2) Diastolic blood pressure less than 60 mm of Hg and more than 95 mm of Hg (3) Pulse rate below 50 / min. and above 105/min. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician / investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental area under the curveTimepoint: 30 min Before dosing, and at 0, 15, 30, 45, 60, 90 and 120 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse eventsTimepoint: End of each study period | — |
Countries
India
Contacts
Public ContactMr P Narender Reddy
Azista Industries Pvt Ltd.
Outcome results
None listed