| CTRI Number |
CTRI/2022/01/039121 [Registered on: 04/01/2022] 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
|
Bioequivalence study on Diclofenac potassium 150 mg XR tablet with Voltaren 150 mg (Diclofenac Sodium) XR tablet in healthy adult human subjects under fasting conditions |
|
Scientific Title of Study
|
An Open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on Diclofenac potassium 150 mg XR tablet of Zona industrial del Este, Venezuela with Voltaren 150 mg (Diclofenac Sodium) XR tablet of Novarties, Colombia in healthy adult human subjects under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/003/0221 version 01 dated 16 Nov 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kadiyala Venkata Sahitya |
| Designation |
Principal investigator |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
#16 & 18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, 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, Yelahanka Main Road,
Chikkabetahalli, 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, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Laboratorios Leti, S.A.V. |
|
|
Primary Sponsor
|
| Name |
Laboratorios Leti SAV |
| Address |
Zona industrial del Este, Avenida 2, Manzana J, Edificio Leti, Guarenas, Venezuela |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Kadiyala Venkata Sahitya |
ICBio Clinical Research Pvt. Ltd. |
II second flour room -2 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 |
Diclofenac potassium 150 mg XR tablet |
Single dose |
| Comparator Agent |
Voltaren 150 mg (Diclofenac Sodium) XR tablet |
single dose |
|
|
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 12.5 to 17.5 grams per deciliter (g/dL) for men and 12.0 to 16.0 g/dL for female.
6 With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no. 9.1).
7 With a normal or clinically non-significant 12-lead ECG.
8 With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
9 Non-smokers and willing to abstain from smoking or chewing any tobacco containing product at least 72.00 hours prior to dosing if have history of smoking habit and throughout the sampling points.
|
|
| ExclusionCriteria |
| Details |
1 Haemoglobin level less than 12.5 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 History of severe infection or major surgery in the past 6 months.
5 History of Minor surgery or fracture within the past 3 months.
6 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.
7 Any major illness or hospitalized within 90 days prior to the first dosing.
8 Any other clinical condition like diarrhea or vomiting within three days prior to dosing.
9 Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during the four weeks before screening.
10 Use of any depot injection or an implant of any drug within three months prior to dosing and throughout the study periods.
11 History or presence of significant gastric or duodenal ulceration.
12 Use of any recreational drug or history of drug addiction.
13 History of difficulty in accessibility of veins in arms.
14 Evidence of an uncooperative attitude.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare rate and extend of orally administered molecule to prove bioequivalence on Diclofenac potassium 150 mg XR tablet of Zona industrial del Este, Venezuela with Voltaren 150 mg (Diclofenac Sodium) XR tablet of Novarties, Colombia in healthy adult human subjects under fasting conditions. |
Day 1 to day 11 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the study subjects after administration of Diclofencac 150 mg XR tablet in healthy adult human subjects under fasting conditions |
Day-1 to day- 11 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2022 |
| Date of Study Completion (India) |
02/12/2021 |
| 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-treatment, two-sequence, two-period, single oral dose, crossover,
bioequivalence study on Diclofenac potassium 150 mg XR tablet of Zona
industrial del Este, Venezuela with Voltaren 150 mg (Diclofenac Sodium) XR tablet of Novarties, Colombia in healthy adult
human subjects under fasting conditions.24 Subjects will be enrolled in the study.
Primary objective:
To compare rate
and extend of orally administered molecule to prove bioequivalence on Diclofenac potassium 150 mg XR tablet of Zona industrial del Este,
Venezuela with Voltaren
150 mg (Diclofenac Sodium) XR tablet of Novarties, Colombia in healthy adult human subjects
under fasting conditions. Secondary objective:
To monitor the safety of the study subjects
after administration of Diclofencac 150 mg XR tablet
in healthy adult human subjects under fasting conditions. |