Clinical Research Directory

Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir in Healthy Volunteers

FAVIDOSE trial is a Phase I randomized, double blind controlled, monocentric, dose escalation clinical trial. The primary purpose of this trial is to evaluate tolerance of high doses of favipiravir for 14 days in healthy volunteers. This trial also looks to characterize favipiravir pharmacokinetics in blood and favipiravir levels in sperm. A pharmacogenetics analysis will be conducted in an attempt to identify genetic variants of metabolism and transport enzymes of favipiravir to explain the inter-individual variability of pharmacokinetic parameters of favipiravir. Three sequential dose levels including distinctive participants: * level 1: D1: 2400 mg BID; D2 to D13: 1600 mg BID and D14: 1600 mg in the morning; * level 2: D1: 2400 mg BID; D2 to D13: 2000 mg BID and D14: 2000 mg in the morning; * level 3: D1: 2400 mg BID; D2 to D13: 2400 mg BID andD14: 2400 mg in the morning. Three study groups of maximum of 8 participants, 6 receiving favipiravir and 2 receiving placebo per dose level, three dose levels proposed. Seven additional participants with the same follow up will be included and randomized (6:1 ratio) at the maximum tolerated dose level to allow a satisfactory accurate characterization of pharmacokinetics and pharmacogenetics of favipiravir and their determinants (maximum 39 participants in total, taking into account 8 participants - 2 per dose level - replaced because loss of follow-up before the end of treatment).

An Escape Room for Nursing Students Taking Pharmacology Classes

The study was planned as a pre-test-post-test single-group, quasi-experimental design to evaluate the effects of the education provided with the escape room game on the level of autonomic nervous system drug knowledge and perceptions of the game experience in nursing students taking the Pharmacology course. The sample of the study will consist of students enrolled in the Nursing Pharmacology course at the Kahramanmaraş İstiklal University, Faculty of Health Sciences, Department of Nursing in the 2024-2025 academic year, who meet the research criteria and agree to participate in the study. The study will be conducted in two stages. In the first stage, the necessary materials for the game development and evaluation process will be prepared and the content validity study of these materials will be conducted. In the second stage, the escape room game will be applied and data will be collected. The data will be collected with the "Descriptive Characteristics Form" and the "Autonomic Nervous System Drug Knowledge Test" (pre-test) before the escape room game, and with the "Autonomic Nervous System Drug Knowledge Test" (post-test) and the "Game Playing Experience Scale" after the game. The analysis of the data will be completed by transferring it to the IBM SPSS Statistics 23 program. H1a = There is a difference between the mean scores of the autonomic nervous system knowledge test of the students who participated in the escape room game before and after the game. H1b = There is no difference between the mean scores of the autonomic nervous system knowledge test of the students who participated in the escape room game before and after the game