Bioequivalence study of Obeticholic Acid in Healthy human subjects

Not Applicable

• Registration Number: CTRI/2021/02/030875
• Lead Sponsor: G C Chemie Pharmie Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Healthy, adult male subjects aged between 18-45 years (both inclusive)

weighing at least 50 kg at the time of screening.

Having a Body Mass Index (BMI) between 18.50 to 24.99 kg/m2 (both inclusive) at the time of screening.

Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations, 12 lead ECG and X-ray chest

(posterior-anterior view) recordings.

Able to comply with the study procedures, in the opinion of the principal investigator.

Compliance with study specific restrictions and prohibitions.

Able to give voluntary written informed consent for participation in the trial.

Non Smoker and Non Alcoholic

Exclusion Criteria

If any subject is having any of the following conditions, then exclude him/her from

participation in this study:

Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.

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.

Systolic blood pressure less than 90 mmHg or more than 140 mmHg at the

time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.

Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the

discretion of the physician/investigator.

Pulse rate below60 beats/minute or above 100 beats/minute at the time of screening.

Respiratory rate below 15 or above 20 breaths per minute.

Oral temperature below 96.2o F or above 99.8 o F at the time of screening.

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.

Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).

History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in of each period.

An unusual or abnormal diet within 48.00 hours prior to study check-in of each

period, whatever reason e.g. because of fasting due to religious reasons.

The presence of clinically significant abnormal laboratory values during screening.

Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis.

A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.

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.

Positive HIV, VDRL/RPR, Hepatitis B and C tests.

Difficulty in swallowing capsule/tablet.

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.

Prior to check-in of Period-One, complete the Inclusion and Exclusion Criteria Form for each volunteer. Only suitable volunteers should be allowed to participate in the study.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified