4.7. Safety Assessment of the Formulation
metabolic alterations
ADVERSE EVENTS, ADVERSE EFFECTS
Throughout the trials, participants’ safety was thoroughly evaluated using a comprehensive examination that covered every aspect of their well-being. These measurements were conducted at the 24 h, 48 h, and 72 h marks post drug administration. This assessment involved the vigilant monitoring of adverse events, along with the meticulous observation of vital signs such as blood pressure, heart rate, and body temperature. In addition, specific blood chemistry parameters were closely examined, including alanine aminotransferase, gamma-alanine aminotransferase, and aspartate aminotransferase. Furthermore, blood chemistry tests were thoughtfully executed on the third day of the trial, providing valuable insights into specific enzymatic activities associated with liver function. These tests specifically focused on alanine aminotransferase, gamma-alanine aminotransferase, and aspartate aminotransferase levels, thereby offering a comprehensive overview of potential metabolic alterations. By implementing this meticulous safety assessment approach, the study aimed to promptly identify and address any adverse effects, ensuring the well-being and health of the participants throughout the trial period. This commitment to safety underscores the ethical and responsible conduct of the research, prioritizing the participants’ health and ensuring the reliability of the study’s findings.