bioequivalence study of Sorafenib 400mg tablet

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Volunteers who accept for participating in this study must: 1.Healthy, adult human, subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening.
2.Having a Body Mass Index (BMI) between 18.50 to 30.00 kg/m2 (both inclusive) at the time of screening.
3.Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations, 12 lead ECG and X-ray chest (posterior-anterior view) recordings.
4.Able to comply with the study procedures, in the opinion of the principal investigator.
5.Compliance with study specific restrictions and prohibitions.
6.Able to give voluntary written informed consent for participation in the trial.
7.Non-smoker and non-alcoholic 8.Subjects willing to follow approved birth control methods for the duration of the study as judged by the investigator(s), such as condom with spermicide, condom with diaphragm, or abstinence, subjects should also not donate sperm during this time.

Exclusion Criteria

If any subject is having any of the following conditions, then exclude him/her from participation in this study: 1.Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
2.History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.
3.Systolic blood pressure less than 90 mmHg or more than 140 mmHg at the time of screening.
5.Pulse rate below 60 beats/minute or above I 00 beats/minute at the time of screening.
6.Respiratory rate below 15 or above 20 breaths per minute.
7.Oral temperature below 96.2Â° For above 99.8 Â° Fat the time of screening.
8.Ingestion of any medicine at any time within 14 days prior to IP administration in period I.
In any such case subject selection will be at the discretion of the principal investigator.
10.History of dehydration from diarrhoea, vomiting or any other reason within a period of24.00 hours prior to study check-in.
11.An unusual or abnormal diet within 48.00 hours prior to study check-in, whatever reason e.g. because of fasting due to religious reasons.
12.The presence of clinically significant abnormal laboratory values during screening.
13.Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis.
14.A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.
15.Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study.
16.Difficulty in swallowing capsule/tablet.
17.Positive HIV, VDRL/RPR, Hepatitis B and C tests 18.Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax and AUC0-72	Predose and at 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hours postdose.

Secondary Outcome Measures

Name	Time	Method
Tmax	Same as mentioned in primary outcome.

Trial Locations

Locations (1): Notrox Research Private Limited,
🇮🇳
Bangalore, KARNATAKA, India
Notrox Research Private Limited,
🇮🇳Bangalore, KARNATAKA, India
Dr Baby Shalini
Principal investigator
9033966783
drshalini@notroxresearch.com