| CTRI Number |
CTRI/2022/03/041028 [Registered on: 11/03/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
An Open label, balanced, randomized, two-period, two-treatment, two-sequence, single oral dose, crossover Bioequivalence study of RIFAIZO PE in healthy adult human subjects under fasting conditions |
|
Scientific Title of Study
|
An Open label, balanced, randomized, two-period, two-treatment, two-sequence, single oral dose, crossover, bioequivalence study on RIFAIZO PE (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of Swiss Parenterals Ltd. with VORACTIV (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of Sandoz Limited in healthy adult human subjects under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/019/1120, version 00 dated 02 Nov 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naresh |
| Designation |
Principal investigator |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
.#16 & 18, ICBio Tower, Chikkabettahalli,
Yelahanka Main Road,
Vidyaranyapura,
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
pi.mail@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Operation Director |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
.#16 & 18, ICBio Tower, Chikkabettahalli,
Yelahanka Main Road,
Vidyaranyapura,
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Operation Director |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
.#16 & 18, ICBio Tower, Chikkabettahalli,
Yelahanka Main Road,
Vidyaranyapura,
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Swiss Parenterals Ltd.
Ahmedabad, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Swiss Parenterals Ltd |
| Address |
Ahmedabad, Gujarat, 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 Naresh |
ICBio Clinical Research Pvt. Ltd. |
room no:2 first floor, Clinical departemnt
#16&18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA |
9900111997
pi.mail@icbiocro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy adult human subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
RIFAIZO PE film coated tablets |
single dose at one time only |
| Comparator Agent |
VORACTIV film coated tablets |
single dose at one time only |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
2.Willing to be available for the entire study period and to comply with protocol requirements.
3.Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.
4.Body mass index in the range of 18 – 30 kg/m2 (both inclusive).
5.Normal haemoglobin between 13.8 to 17.2 grams per deciliter (g/dL) for men and 12.1 to 15.1 g/dL for female.
6.Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period.
7.With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no. 9.1).
8.With a normal or clinically non-significant 12-lead ECG.
9.With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
|
|
| ExclusionCriteria |
| Details |
1.Haemoglobin level less than 13.5 grams per deciliter for men and 12 grams per deciliter for women.
2.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs.
3.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
4.Taking any iron preparation already at the time of enrolment.
5.History of severe infection or major surgery in the past 6 months.
6.History of Minor surgery or fracture within the past 3 months.
7.Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction.
8.Any major illness or hospitalized within 90 days prior to the first dosing.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare rate and extend of orally administered molecule to prove bioequivalence on RIFAIZO PE (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of Swiss Parenterals Ltd. with VORACTIV (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of Sandoz Limited in healthy adult human subjects under fasting conditions. |
from Day 1 to day 11 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor and assess safety and tolerability of the investigational products in healthy adult, human subjects under fasting condition. |
from Day 1 to day 11 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2022 |
| Date of Study Completion (India) |
20/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="11" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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,
balanced, randomized, two-period, two-treatment, two-sequence, single oral
dose, crossover, bioequivalence study on RIFAIZO PE (Rifampicin
150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) film
coated tablets of Swiss Parenterals Ltd. with VORACTIV (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg +
Ethambutol 275mg) film coated tablets of Sandoz Limited in healthy adult human subjects under fasting
conditions.
Primary
objective:
To compare rate and extend of orally
administered molecule to prove bioequivalence on RIFAIZO PE (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg +
Ethambutol 275mg) film coated tablets of Swiss Parenterals Ltd. with VORACTIV
(Rifampicin 150mg + Isoniazide 75mg +
Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of Sandoz
Limited in healthy adult human subjects under fasting conditions.
Secondary
objective:
To monitor and assess
safety and tolerability of the investigational products in healthy adult, human
subjects under fasting condition
32 subjects will be enrolled in the study. |