| CTRI Number |
CTRI/2022/11/047283 [Registered on: 14/11/2022] Trial Registered Prospectively |
| Last Modified On: |
01/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparative Bioavailability study of Diclofenac Topical solution (4%) vs Diclofenac Gel (1%) |
|
Scientific Title of Study
|
A Randomized, Open Label, Balanced, Four Treatment, Four Period, Four-
Sequence, Single Dose, Four way Crossover, Comparative Bioavailability Study of Test
product T1: Dynapar QPS® (Diclofenac Diethylamine and Absolute Alcohol Non-
Aqueous Topical Solution) (Dose: 1ml equivalent to 40 mg diclofenac sodium) and Test
product T2: Dynapar QPS® (Diclofenac Diethylamine and Absolute Alcohol Non-
Aqueous Topical Solution) (Dose: 2ml equivalent to 80 mg diclofenac sodium) of
Troikaa Pharmaceuticals Ltd., India with Reference product R1: Voveran Emulgel of
Novartis India Limited (Dose: 4 gm equivalent to 40 mg diclofenac sodium) and
Reference product R2: Voveran Emulgel of Novartis India Limited (Dose: 8 gm
equivalent to 80 mg diclofenac sodium) in Normal, Healthy, Adult, Human Subjects
under Fasting Conditions |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 22-VIN-0133 Version 01 29 Sep 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaibhav Patel |
| Designation |
Principal Investigator |
| Affiliation |
Veeda Clinical Research Ltd. |
| Address |
Veeda Clinical Research Pvt. Ltd. Shivalik Plaza Near I.I.M. Ambawadi Ahmedabad – 380015 Gujarat India
Ahmadabad
GUJARAT
380 051
India |
| Phone |
|
| Fax |
|
| Email |
Vaibhav.P2197@veedacr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Vivek Kumar Agarwal |
| Designation |
Senior General Manager |
| Affiliation |
Troikaa Pharmaceuticals Ltd. |
| Address |
Troikaa Pharmaceuticals Ltd. Commerce House-I Satya Marg Bodakdev Ahmedabad -380054 Gujarat India
Ahmadabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
7926856242 |
| Fax |
|
| Email |
vivekagarwal@troikaapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vivek Kumar Agarwal |
| Designation |
Senior General Manager |
| Affiliation |
Troikaa Pharmaceuticals Ltd. |
| Address |
Troikaa Pharmaceuticals Ltd. Commerce House-I Satya Marg Bodakdev Ahmedabad -380054 Gujarat India
Ahmadabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
7926856242 |
| Fax |
|
| Email |
vivekagarwal@troikaapharma.com |
|
|
Source of Monetary or Material Support
|
| Troikaa Pharmaceuticals Ltd. Commerce House-I Satya Marg Bodakdev Ahmedabad-380054 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Troikaa Pharmaceuticals Ltd |
| Address |
Commerce House-I Satya Marg Bodakdev Ahmedabad-380054 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 Vaibhav Patel |
Veeda Clinical Research Ltd. |
Veeda Clinical Research Ltd.
1st, 2nd, 3rd & 4th Floor
VEDANT Complex, Nr. Y.M.C.A. Club,
S.G. Highway Road, Vejalpur,
Ahmedabad 380 051, Gujarat, India
Ahmadabad
GUJARAT |
79-67773000
Vaibhav.P2197@veedacr.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Anveshhan Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Reference product (R1): Voveran Emulgel |
Reference product (R1): Voveran Emulgel (contains Diclofenac
Diethylamine 1.16% w/w equivalent to diclofenac sodium 1% w/w)
of Novartis India Limited
Reference product 1: 4 gm will be applied one time per period as per randomisation. |
| Comparator Agent |
Reference product (R2 - same batch as R1): Voveran Emulgel |
Reference product (R2 - same batch as R1): Voveran Emulgel
(contains Diclofenac Diethylamine 1.16% w/w equivalent to
diclofenac sodium 1%w/w) of Novartis India Limited
Reference Product 2: 8 gm will be applied one time per period as per randomisation. |
| Intervention |
Test product (T1): Dynapar QPS®
Non-Aqueous Topical Solution) |
(Diclofenac Diethylamine and
Absolute Alcohol Non-Aqueous Topical Solution) (contains
Diclofenac Diethylamine 4.64% w/v Equivalent to Diclofenac
Sodium 4.00% w/v and Absolute Alcohol 10.00% v/v) of Troikaa Pharmaceuticals Ltd.
Test Product:1ml will be applied one time per period as per randomisation. |
| Intervention |
Test product (T2 - same batch as T1): Dynapar QPS® |
Test product (T2 - same batch as T1): Dynapar QPS® (Diclofenac
Diethylamine and Absolute Alcohol Non-Aqueous Topical
Solution) (contains Diclofenac Diethylamine 4.64% w/v Equivalent
to Diclofenac Sodium 4.00% w/v and Absolute Alcohol 10.00%
v/v) Troikaa Pharmaceuticals Ltd.
Test Product 2: 2ml will be applied one time per period as per randomisation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged between 18 and 45 years (both inclusive).
2. Subjects weight within normal range according to normal values for Body Mass Index (between 18.50 and 30.00 kg/m2) (both inclusive) with minimum of greater than equal to 55 kg weight.
3. Subjects with Haemoglobin greater than equal to 12.0 gm % at the time of screening.
4. Subjects with absence of clinically significant dermatological disease or condition or skin cancer.
5. Subjects with absence of open sores or large scars at application site or any type of skin lesions (such as swelling, rashes or abrasion).
6. Subjects with normal health as determined by personal medical history,clinical examination and laboratory examinations within the clinically
acceptable range.
7. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
8. Subjects having clinically acceptable chest X-Ray (PA view).
9. Subjects having negative urine screen for drugs of abuse (includingamphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and
morphine).
10. Subjects having negative Urine alcohol /alcohol breath test.
11.Subjects willing to adhere to the protocol requirements and to provide written informed consent.
12. For male Subjects:
-Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by theinvestigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence. Subjects should also not donate sperm during study period.
13. Subjects having negative urine pregnancy test at screening and negative serum beta-hCG Pregnancy test on admission day of period 01 (only for female subjects).
14. For Female Subjects:
-Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the
investigator(s), such as intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam.or
-Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above
or
-Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject). |
|
| ExclusionCriteria |
| Details |
1. Hypersensitivity to Diclofenac or related class of drugs or any of its excipients or heparin.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal,
gastrointestinal, endocrine, immunological, dermatological, neurological,
urogenital or psychiatric disease or disorder.
3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to dosing in period 01.
4. Presence of alcoholism or drug abuse.
5. History or presence of significant smoking (more than 10 cigarettes or beedis/day).
6. Presence of skin conditions / infections and excessive hairs that might interfere with absorption of drug from application site like Lipoma, rash, scars, warts etc.
7. History or presence of significant dermatologic diseases or conditions, such as atopy, psoriasis, vitiligo or conditions known to alter skin appearance.
8. Presence of excessive hair growth, recently shaved excessive oily, tattoo or any birthmark on dose application site.
9. History or presence of asthma, urticaria or other significant allergic reactions.
10. History or presence of significant gastric and/or duodenal ulceration
11. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
12. History or presence of cancer or basal or squamous cell carcinoma.
13. Difficulty with donating blood.
14. Use of any prescribed medication or OTC medication including vaccine and
vitamins during last 30 days prior to dosing in period 01.
15. Major illness within past 3 months.
16. Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
17. Consumption of xanthine-containing products, tobacco containing products, alcohol or alcoholic products for within 48.00 hours prior to dosing in period 01.
18. Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to dosing of period 01.
19. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
20. History or presence of significant easy bruising or bleeding.
21. History or presence of significant recent trauma.
22. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
23. Female subjects who are currently pregnant or breast feeding. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
PK Parameters: Cmax, AUC(0-t), AUC(0-∞), Tmax, AUC_% Extrap_obs, t1/2 and Kel.
|
A total of 17 blood samples each of 6.0 ml will be collected during
each study period.
The pre-dose blood sample (0.00 hr) will be collected within one
hour prior to the dosing and post-dose blood samples will be drawn
at 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00,
12.00, 14.00, 16.00, 20.00 and 24.00 hours following drug
administration in each period.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of subjects. |
Vitals (Sitting Blood pressure and Radial pulse rate) will be measured pre-dose and at 3.00, 6.00 and 13.00 hours after dosing in each period.
Physical and Systemic examination will be done on admission day and at end of study. Dose application site will be examined for any skin reaction before start time of dosing and at 0.5,1,2,3,4,5,6 and 12 hours post dose and during check-out |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2022 |
| 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="1"
Days="16" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
This bioavailability study is planned to evaluate comparative bioavailability of Dynapar QPS® (Diclofenac Diethylamine and Absolute Alcohol Non-Aqueous Topical Solution) of Troikaa Pharmaceuticals Ltd., India with Voveran Emulgel sodium) of Novartis India Limited in 08 normal, healthy, adult, human subjects, under fasting conditions. Total expected duration of the study will be approximately 45 days from the day of admission of first period till end of the study. Following PK parameters: Cmax, AUC(0-t), AUC(0-∞), Tmax, AUC_%Extrap_obs, t1/2 and Kel will be measured. |