Study Design
A single centre, open-label, randomised, single oral dose, cross-over, two-sequence, two-period study was conducted in 30 healthy, Caucasian, adult, male, human subjects under fasting conditions. This study was reviewed and approved by the Ethical Committee (Approval Date: 30.04.2020) and Turkish Medicines and Medical Devices Agency (Approval Date: 04.05.2020), and was held in Turkey according to the regulations run by Ministry of Health of the Republic of Turkey which are in compliance with Declaration of Helsinki and Good Clinical Principles (GCP) [7].
This study was conducted at FARMAGEN-Good Clinical Practice Center, Gaziantep, Turkey. The clinical study Spanned a period of approximately 9 days including prestudy screening, isolation period (5 days), wash-out period (48 hours) and final examination. The standard laboratory examinations in blood and urine were done consistent with the study protocol and the volunteers were checked for presence of HBsAg, HCV-Ab and HIV-Ab in serum. Also Covid-19 PCR tests were applied to the volunteers before isolation period and hospitalization. They were requested to provide a urine sample for a drug screen which include “amphetamines, cannabinoids, benzodiazepines, cocaine, opioids and barbiturates” and an alcohol breath test on entry examinations. All laboratory tests were carried out in a certified local laboratory.
Depending on the suitability of the volunteers clinical examination and laboratory results, isolation period was provided for 4 nights in single rooms reserved and it was important that the volunteers participating in the study do not come into contact with each other during the isolation and that the rules of isolation were followed due to Covid-19 Pandemic. After isolation period volunteers were transferred to vlinical center depending on negative Covid-19 PCR tests done once more.
A total of 30 subjects have been randomised and 29 subjects completed the clinical study. 10-hour fasted subjects were not allowed to drink water from 1 h before until 1 h after the administration of study products, except while dosing and they remained fasted until 4 hours after administration. Immediately after pre-dose sampling, 1 tablet of the test drug or 1 tablet of the reference drug (200 mg Favipiravir each case), were taken by the subjects with 240 mL of water. After the washout period (approximately 48 hours); in Period II, the subjects were administered the other drug they did not take in the Period I. The same procedures were applied in each period.