| CTRI Number |
CTRI/2012/11/003106 [Registered on: 14/11/2012] Trial Registered Retrospectively |
| Last Modified On: |
25/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
Relative bioavailability of diclofenac potassium different formulations in healthy subjects. |
|
Scientific Title of Study
|
An open label, randomized, three period, six sequence, crossover study to determine the bioavailability of diclofenac potassium soft-gelatin capsule as compared to diclofenac potassium powder for oral solution and diclofenac potassium tablet in healthy subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCAT458M2101, Version No. v01 , dated 04-May-2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Kumar Anand |
| Designation |
Principal Investigator |
| Affiliation |
Lotus Labs Pvt. Ltd. |
| Address |
Lotus Labs Pvt. Ltd. No-02, M.M Towers, Jakkur Plantations, Yelahanka Hobli, Bangalore
Bangalore
KARNATAKA
560064
India |
| Phone |
9900103514 |
| Fax |
08028567270 |
| Email |
anil_ka@lotuslabs.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prafulla Bhad |
| Designation |
Clinical Trial Leader |
| Affiliation |
Novartis Healthcare Pvt. Ltd. |
| Address |
Novartis Healthcare Pvt. Ltd. Building # 6 Raheja Mind Space, Hitech City Madhapur / Hyderabad, Rangareddy
Hyderabad
ANDHRA PRADESH
500 081
India |
| Phone |
04067673287 |
| Fax |
04067671400 |
| Email |
prafulla.bhad@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Prafulla Bhad |
| Designation |
Clinical Trial Leader |
| Affiliation |
Novartis Healthcare Pvt. Ltd. |
| Address |
Novartis Healthcare Pvt. Ltd. Building # 6 Raheja Mind Space, Hitech City Madhapur / Hyderabad, Rangareddy
Hyderabad
ANDHRA PRADESH
500 081
India |
| Phone |
04067673287 |
| Fax |
04067671400 |
| Email |
prafulla.bhad@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Healthcare Private Limited |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare private Limited, Sandoz House, Dr. Annie Besant Road, Worli, Mumbai-400018, Maharashtra, India |
| 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 Anil Kumar Anand |
Lotus Labs Pvt. Ltd. |
No-02, M.M Towers, Jakkur Plantations, Yelahanka Hobli, Bangalore
Bangalore
KARNATAKA |
918028567270
08028567270
anil_ka@lotuslabs.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I. E. C. Consultants, "Darussalam", 598 2nd Cross, 3rd Block, Koramangala, Bangalore - 560034, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac 50 mg powder for oral solution |
Single oral dose once daily for one day |
| Comparator Agent |
Diclofenac 50 mg tablet |
Single oral dose once daily for one day |
| Intervention |
Diclofenac potassium soft-gelatin (50mg) capsule |
Single oral dose once daily for one day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female subjects
2. Subjects must weigh atleast 50 kg and their BMI should be within range of 18-30 kg/m2
3. Women of child-bearing potential must use effective contraception during the study.
|
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
2. Pregnant or nursing (lactating) women
3. History of clinically significant ECG abnormalities, malignancy of any organ system, history of immunodeficiency diseases; of drug or alcohol abuse.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare bioavailability of 50 mg diclofenac potassium formulations in healthy subjects under fasting conditions.
|
Based on blood samples collected at multiple time points over 12 hours post dose. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety of diclofenac potassium formulations used in this study in healthy subjects. |
Monitoring of AE throughout the study |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
15/11/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open-label, randomized, crossover study in healthy subjects. The study will consists of 28-days screening period , three baseline period(s) (one before each treatment period), three treatment periods, washout period of of 3-7 days from the last dosing followed by end of study evaluation approximately 24 hours after last drug administration.
|
Initial Baseline: Subjects who meet the eligibility criteria at screening will be admitted to baseline evaluations. All baseline safety evaluation results must be available prior to dosing. |
Treatment Period: The administration of the diclofenac formulations will take place in fasting conditions in all the three periods with 240 mL of water as per the randomization list. Following administration of the appropriate diclofenac formulation, blood samples will be collected at specified timepoints up to 12 hours post dose to estimate diclofenac concentrations. Subjects will be domiciled for approximately 36 hours (Day -1 to Day 2). Subjects will be discharged from the clinical site after completing the assessments scheduled on Day 2 in each period. Subjects will come back to the site for treatment Period 2 and 3 after a washout of at least 3 days from the last dose. They will receive the treatment that is different from the one
received in period 1, and they will repeat all procedures they underwent in period 1 in period 2 and 3.
For all treatment groups, standard lunch, snacks and dinner will be served at approximately 4, 8 and 12 hours post dose.
In addition to the routine safety assessments performed at specified time points during the study, the subjects will also be monitored for adverse events throughout the study. Any AE occurring during this time will be evaluated by the investigator as to whether it is related to the study drug. |