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.