In-vivo Bioequivalence Study of Ibrutinib 140 mg capsule of The Test Drug (ACTLOUVIKA®, 140 mg ., Actero Pharma, Iran) in Compared with The Reference Drug (IMBRUVICA® 140 mg ., Jenssen Inc. Swiss) In Iranian Healthy Volunteers

Bioequivalence study of Ibrutinib 140 mg (ACTLOUVIKA) capsule manufactured by Actero Pharma, Iran. versus originator brand (IMBRUVICA® 140 mg , Jenssen Inc. Swiss) in fasting condition in healthy volunteers.

Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization

The study is a single-blinded (Volunteers), cross-over and fasting, and on two series of healthy volunteers. The study will be done in two periods (24h). The interval between these two periods is 1 weeks. In the first round of the study, the candidates were divided into two groups the first group received a test capsule and the second group received a brand capsule . Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. Sampling is performed in Radin laboratory in Tabriz.

Inclusion Criteria: General Health (Liver, Heart, and Kidney), Body Mass Index (18-30), Informed consent, Age (18-55 years old) Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcohol and drug addiction, History of allergy to Ibrutinib

Intervention group 1: (IMBRUVICA® 140 mg , Jenssen Inc. Swiss) as a reference Intervention group 2: Ibrutinib 140 mg (ACTLOUVIKA®, 140 mg , Actero Pharma, Iran) as a test

Maximum drug concentration, Time to reach maximum drug concentration

People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and healthy volunteers are identified. Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball poured into a container and mixed. The balls are then removed randomly from the container. The first 12 no.s are considered as (first sequence: test medicine ) and the second 12 no.s are considered as (second sequence: originator brand recipient). The volunteers don't have any information about taking the test drug or brand drug

This study is a single-blinded clinical trial (volunteers). Test and Originator brand's capsules are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form.

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