| CTRI Number |
CTRI/2021/02/030875 [Registered on: 01/02/2021] Trial Registered Prospectively |
| Last Modified On: |
20/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of Obeticholic Acid in Healthy human subjects |
|
Scientific Title of Study
|
An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose oral bioequivalence study of Obeticholic acid 10 mg tablet (T) Manufactured by G.C.Chemie Pharmie Ltd at M/s. Steril-Gene Life Science (P) Ltd., No. 45, Mangalam Main Raod,
Mangalam Village, Villianur Commune, Puducherry – 605 110 with OCALIVA (Obeticholic acid) Tablets 10 mg (R) Manufactured by Intercept Pharmaceuticals in normal healthy, adult, male subjects under Fasting condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| S-19-481 V: 01; Dated: 06.08.2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Baby Shalini S |
| Designation |
Principal Investigator |
| Affiliation |
Notorox Research Pvt Limited |
| Address |
NOTROX RESEARCH PVT LTD
No.19/3 Second floor Bikasipura Rroad Off Kanakapura road Behind Metro cash and carry Bangalore district Karnataka state
India
Bangalore
KARNATAKA
560062
India |
| Phone |
|
| Fax |
|
| Email |
babyshalini581993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baby Shalini S |
| Designation |
Principal Investigator |
| Affiliation |
Notorox Research Pvt Limited |
| Address |
NOTROX RESEARCH PVT LTD
No.19/3 Second floor Bikasipura road Off Kanakapura Road Behind Metro cash and carry Bangalore district Karnataka state
India
Bangalore
KARNATAKA
560062
India |
| Phone |
|
| Fax |
|
| Email |
babyshalini581993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Baby Shalini S |
| Designation |
Principal Investigator |
| Affiliation |
Notorox Research Pvt Limited |
| Address |
NOTROX RESEARCH PVT LTD
No.19/3 Second floor Bikasipura road Off Kanakapura Road Behind Metro cash and carry Bangalore district Karnataka state
India
Bangalore
KARNATAKA
560062
India |
| Phone |
|
| Fax |
|
| Email |
babyshalini581993@gmail.com |
|
|
Source of Monetary or Material Support
|
| NOTROX RESEARCH PVT LTD
No.19/3 Second floor Bikasipura road Off Kanakapura Road Behind Metro cash and carry Bangalore district Karnataka state
India |
|
|
Primary Sponsor
|
| Name |
G C Chemie Pharmie Limited |
| Address |
5/C, Shree Laxmi Indl.Estte,
New Link Road, Andheri (West), Mumbai
400053, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Baby Shalini S |
NOTROX RESEARCH PVT LTD |
No.19/3, Second floor, Bikasipura Road, Off Kanakapura Road,
(Behind Metro cash and carry),
Bangalore district-560062
Karnataka state, India
Bangalore
KARNATAKA |
9033966183
babyshalini581993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Durgamba Independent Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Obeticholic Acid 10mg |
Maximum Dosage: 10 mg once daily
Route: Oral
Frequency: OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times thehighest recommended dosage), as early as one month after starting treatment with obeticholic Acid |
| Comparator Agent |
Ocaliva 10mg Tablet |
Maximum Dosage: 10 mg once daily
Route: Oral
Frequency: OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times thehighest recommended dosage), as early as one month after starting treatment with OCALIVA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the rate and extent of absorption of Obeticholic acid 10
mg tablet (T) Manufactured by G.C. Chemie Pharmie Ltd, India with
OCALIVA®(Obeticholic acid) Tablets10mg (R) Manufactured by Intercept Pharmaceuticals. |
A single pre-dose (0.00) blood sample of 3.0 mL will be collected in each period. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTAvacutainers.
The post-dose blood samples of 3.0 mL each will be collected at 00.17, 00.33, 00.50, 00.67, 00.83, 01.00, 01.25, 01.50, 01.75, 02.00, 03.50, 05.00, 06.50, 08.00, 09.50, 11.00, 14.00, 18.00, 24.00, 36.00,
48.00 and 72.00 hours post drug administration in each period.
36.00, 48.00 and 72.00 hours Ambulatory Visit
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor the adverse events and to ensure the safety of the subjects
following administration of a single dose of Obeticholic acid 10 mg tablet. |
A single pre-dose (0.00) blood sample of 3.0 mL will be collected in each period. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTAvacutainers.
The post-dose blood samples of 3.0 mL each will be collected at 00.17, 00.33, 00.50, 00.67, 00.83, 01.00, 01.25, 01.50, 01.75, 02.00, 03.50, 05.00, 06.50, 08.00, 09.50, 11.00, 14.00, 18.00, 24.00, 36.00,
48.00 and 72.00 hours post drug administration in each period.
36.00, 48.00 and 72.00 hours Ambulatory Visit
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An open label, randomized, balanced, two treatment, two sequence, two
period, cross-over, single-dose oral bioequivalence study of Obeticholic
acid 10 mg tablet (T) Manufactured by G.C.Chemie Pharmie Ltd at M/s.
Steril-Gene Life Science (P) Ltd., No. 45, Mangalam Main Raod,
Mangalam Village, Villianur Commune, Puducherry – 605 110 with
OCALIVA® (Obeticholic acid) Tablets 10 mg (R) Manufactured by
Intercept Pharmaceuticals in normal healthy, adult, male subjects under
Fasting condition
CDSCO recommend to conduct BE study as part of Subsequent New Drug application |