| CTRI Number |
CTRI/2023/06/054540 [Registered on: 28/06/2023] Trial Registered Prospectively |
| Last Modified On: |
01/11/2023 |
| 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 (2%) vs Diclofenac aerosol spray (1%) |
|
Scientific Title of Study
|
A randomized, open-label, two-treatment, two-period, two- sequence, single-dose,balanced, crossover, comparative bioavailability study of Dynapar QPS Plus of Troikaa
Pharmaceuticals Ltd., India with Volini Aerosol Spray of Sun Pharmaceutical Industries
Ltd, India in healthy, adult, human subjects under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 22-VIN-0495 version 01 dated 02 May 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aamir Raza Mansuri |
| Designation |
Principal Investigator |
| Affiliation |
Veeda Clinical Research Ltd. |
| Address |
VEDANT Complex, Near YMCA Club
SG Highway, Vejalpur
Ahmadabad
GUJARAT
380 051
India |
| Phone |
79-67773000 |
| Fax |
|
| Email |
Aamirraza.M2588@veedacr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Vivek Kumar Agarwal |
| Designation |
Senior General Manager |
| Affiliation |
Troikaa Pharmaceuticals Ltd. |
| Address |
Troikaa House-I Satya Marg Bodakdev
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 House-I Satya Marg Bodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
7926856242 |
| Fax |
|
| Email |
vivekagarwal@troikaapharma.com |
|
|
Source of Monetary or Material Support
|
| Troikaa Pharmaceuticals Ltd. Troikaa House-I Satya Marg Bodakdev Ahmedabad-380054 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Troikaa Pharmaceuticals Ltd |
| Address |
Troikaa 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 Aamir Raza Mansuri |
Veeda Clinical Research Ltd |
Vedant complex
Nr YMCA club
SG highway
Vejalpur
Ahmedabad
Ahmadabad
GUJARAT |
79-67773000
aamirraza.M2588@veedacr.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Conscience Independent Ethics Committee |
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 |
Dynapar QPS Plus 2.32% w/v of Troikaa Pharmaceuticals Ltd |
Dynapar QPS Plus 2.32% w/v (Diclofenac diethylamine BP: 2.32% w/v equivalent to Diclofenac sodium IP
(1ml of solution equivalent to 20 mg diclofenac sodium)
Dose: Single topical dose 2 ml (equivalent to 40 mg diclofenac sodium)
Duration of Intervention: 1 day (single dose) |
| Comparator Agent |
Volini Spray 1.16% w/w of
Sun Pharmaceutical Industries Ltd, India. |
Volini Spray 1.16% w/w (Diclofenac Deithylamine IP 1.16% w/w equivalent to Diclofenac Sodium 1% w/w, (1gm of solution equivalent to 10 mg diclofenac sodium)
Dose: Single topical dose approximately 4 gm (equivalent to 40 mg diclofenac sodium)
Duration of Intervention: 1 day (single dose) |
|
|
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) of both gender.
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 greater than equal to 50 kg weight.
3 Subject with hemoglobin level greater than equal to 11.5 gm percent at the time of screening.
4 Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable range.
5 Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
6 Subjects having clinically acceptable chest X-Ray (PA view), if taken.
7 Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
8 Subjects having negative Urine alcohol /alcohol breath test.
9 Subjects who are Non-smokers.
10 Subjects willing to adhere to the protocol requirements and to provide written informed consent.
11 For male Subjects:
Subjects willing to follow approved birth control methods for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence. Subjects should also not donate sperm during study period.
12 Subjects having negative urine pregnancy test at screening and negative serum Beta-hCG Pregnancy test on admission day of period 01. (For female subject).
13 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 plus diaphragm, condom plus spermicidal or foam.
Or
Postmenopausal for at least 1 year, or if less than 1 year, then 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 admission of period-01.
4 Presence of alcoholism or drug abuse.
5 History or presence of asthma, urticaria or other significant allergic reactions.
6 History or presence of significant gastric and/or duodenal ulceration.
7 History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
8 History or presence of cancer or basal or squamous cell carcinoma.
9 Difficulty with donating blood.
10 Use of any prescribed medication or OTC medication including vaccine, vitamins and herbal remedies during last 30 days prior to admission of period 01.
11 Major illness within past 3 months.
12 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.
13 Consumption of xanthine-containing products, tobacco containing products, alcohol or alcoholic products for within 48.00 hours prior to admission of period 01.
14 Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission of period 01.
15 Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
16 History or presence of significant easy bruising or bleeding.
17 History or presence of significant recent trauma.
18 Any contraindication to cannulation or blood sampling.
19 Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
20 Female subjects who are currently pregnant or breast feeding.
21 Subjects who have Bruises, damaged skin, eczema or wounds on the application site, or the application site inappropriate for applying the IMP as per PI discretion.
|
|
|
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 & Kel. |
A total of 19 blood samples will be collected during each study period.
The pre-dose blood sample of 4.0 mL (0.00 hour) will be collected within one hour prior to scheduled time of dosing in each study period.
The post-dose blood samples of 4.0 mL each 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, 18.00, 20.00, 22.00 & 24.00 hours after dosing in each study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety & tolerability of subjects |
Vital signs (blood pressure & radial pulse rate) will be measured before
dosing of investigational products (within one hour prior to dosing) & at
1.00, 3.00, 6.00, and 13.00 hours after dosing in each period.
Post-dose blood pressure and radial pulse rate will be measured within ± 45 minutes of the scheduled time in sitting posture. |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
Final Enrollment numbers achieved (Total)= "8"
Final Enrollment numbers achieved (India)="8" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/07/2023 |
| Date of Study Completion (India) |
27/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="17" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is
planned to compare bioavailability of
Dynapar QPS Plus of Troikaa Pharmaceuticals Ltd., India with Volini Aerosol
Spray of Sun Pharmaceutical Industries Ltd, in healthy, adult, human subjects
under fasting conditions.
Total expected duration
of the study will be approximately 17-18 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.
This is DCGI approved
product and We have already registered phase III clinical trial of Dynapar QPS
Plus with CTRI registration number CTRI/2011/091/000001 [Registered on:
11/01/2011] with title of study: A randomized, two arm, open label, active controlled,
multicentric clinical study to evaluate the efficacy and safety of atopical
formulations of diclofenac (2.32% w/v solution) with Methyl Salicylate 10% w/v
and Menthol 5% w/v versus a topical Diclofenac Gel (1.16%
w/w) with Methyl Salicylate 10% w/w and Menthol 5% w/w in acute low back ache
and sprains.
|