Single-dose bioequivalence studies of Gemifloxacin tablets (320 mg) in healthy volunteers

Administration of test (generic) and reference (brand) products to healthy subjects Comparison of bioavailability and pharmacokinetics of two products Evaluation of interchangeability of two products

This clinical trial study with control group was conducted on 26 patients with parallel, double-blind, random allocation, and bio-equivalence phase. 26 healthy volunteers after passing the inclusion and exclusion criteria will be divided into two groups of test and reference. Then, in the second period, the group that received the test drug will receive the reference drug and the other group will receive the test drug.

This study was single-dose, randomized, and crossover. In this way, after completing the consent form and being aware of the drug and its side effects, the candidates consume the test product in one period and the reference product in the other period. This study was conducted at Shahid Beheshti School of Pharmacy.

Inclusion criteria: Healthy volunteers aged 18 to 50 years Exclusion criteria: History of liver, kidney and cardiovascular diseases that can affect drug clearance from body History of taking any medication in the last two weeks Creatinine above 2

Receiving test product Receiving reference product

The variables of this study include the maximum plasma concentration of the drug, the time to reach the maximum plasma concentration of the drug and the area below the concentration versus time curve. The first two variables are a measure of drug uptake rate and the third variable is a measure of drug uptake.

In order to allocate randomly in this study, the simple and limited random allocation rule will be used. This method represents a large block for the total sample size, which means that the balance in the number of people assigned to each group will be achieved at the end. For this purpose, 26 candidates who meet the inclusion criteria will be selected first. Then, 13 lots for the intervention group and 13 lots for the control group are placed in a lottery container. Then, each of these 26 people randomly removes a lottery ticket from the container without replacement and deliver the lottery to the person in charge of the project and the group allocation to the individual is determined (the individual, the doctor, and the responsible nurse are not aware of the group allocation to the individual). In the second phase of the study, the individual in the control group is transferred to the intervention group and vice versa.

Candidates receive medication twice. Once Iranian product (generic) and once the foreign product (reference). Volunteers and study physicians are not aware of what products they have received at every turn. Because the medicine is taken out of its box and blister and given to the volunteers, they will have no knowledge of the type of medicine. The new drug is made in terms of color, smell, taste, consistency, and all appearance characteristics similar to the reference drug so that the participants are blind in this regard.