| CTRI Number |
CTRI/2024/05/067180 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| 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 Ketorolac Tromethamine
Sublingual Tablet 10 mg in healthy human subjects |
|
Scientific Title of Study
|
An Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence,
Two-Period, Crossover, Comparative Bioavailability Study of Ketorolac Tromethamine
Sublingual Tablet 10 mg of Troikaa Pharmaceuticals Ltd., India and Ketorol – DT
(Ketorolac Tromethamine Dispersible Tablet 10 mg) of Dr. Reddys Laboratories Ltd.,
India in healthy, adult, human subjects under fed condition. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 22-VIN-0433 version 01 Amendment no.01 dated 29.02.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Imran Ghanchi |
| Designation |
Principal Investigator |
| Affiliation |
Veeda Clinical Research Ltd. |
| Address |
Veeda Clinical Research Ltd.
2nd, 3rd & 4th Floor,
Shivalik Plaza-A,
Near IIM Ambawadi,
Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
7967773000 |
| Fax |
|
| Email |
Imran.G2001@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
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
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 Imran Ghanchi |
Veeda Clinical Research Ltd |
3rd 4th 5th floor
Shivalik Plaza A
Near IIM
Ambawadi
Ahmadabad
GUJARAT |
7967773000
Imran.G2001@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 human volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketorol – DT (Ketorolac Tromethamine Dispersible Tablets
10 mg)
Manufactured by: Dr. Reddys Laboratories Ltd., India |
Ketorol – DT is a dispersible tablet. Tablet has to be disintegrated in 5 ml of water
Dose: 10 mg
Frequency: Single dose (one tablet)
Route of administration: Oral
Total duration of Intervention : 1 day |
| Intervention |
Ketorolac Tromethamine Sublingual Tablet 10mg Manufactured by: Troikaa Pharmaceuticals Ltd., India |
Test product is Ketorolac sublingual tablet 10 mg to be administered orally under the tongue
Dose: 10 mg single dose
Frequency: Single dose (one tablet)
Route administration: Sublingual
Total duration of Intervention : 1 day
|
|
|
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 per m2) (both inclusive) with minimum of 50 kg weight.
3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable range.
4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
5. Subjects having clinically acceptable chest X-Ray (PA view) if taken.
6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
7. Subjects having negative Urine alcohol /alcohol breath test.
8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.
9. For Male Subjects:
Subjects willing to follow approved birth control methods (a double barrier method) 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.
10. 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).
11. 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 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 Ketorolac Tromethamine, aspirin or NSAIDs or related class of drugs or any of its excipients.
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 1 month prior to dosing in period 01.
4. Presence of significant alcoholism or drug abuse.
5. History or presence of significant smoking.
6. History or presence of asthma, urticaria or other significant allergic reactions.
7. History or presence of significant gastric and/or duodenal ulceration.
8. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
9. History or presence of cancer or basal or squamous cell carcinoma.
10. Difficulty with donating blood.
11. Difficulty in swallowing solids like tablets or capsules.
12. Use of any prescribed medication or OTC medication and vaccine during last 30 days prior to admission in period 01.
13. Major illness within past 3 months.
14. 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.
15. Consumption of caffeine or xanthine-containing products, tobacco containing products or alcohol or alcoholic products within 48 hours prior to admission in period 01.
16. Consumption of grapefruit or grapefruit juice containing products within 72 hours prior to admission of period 01.
17. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
18. History or presence of significant easy bruising or bleeding.
19. History or presence of significant recent trauma.
20. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
21. 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 & Kel |
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 0.083,
0.17, 0.25, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00,
5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours following drug
administration in each period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Following parameters will be measures as safety outcomes:
1. blood pressure
2. radial pulse rate, body
3. temperature
4.respiratory rate |
Vitals (sitting blood pressure & radial pulse rate) will be measured before
dosing of investigational products (within 2 hours prior to dosing) & at 1.00,
3.00, 6.00 & 13.00 hours after dosing in each period. |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
26/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 is an Open Label, Balanced, Randomized, Single-Dose,
Two-Treatment, Two-Sequence, Two-Period, Crossover, Comparative Bioavailability
Study of Ketorolac Tromethamine Sublingual Tablet 10 mg of Troikaa
Pharmaceuticals Ltd., India and Ketorol – DT
(Ketorolac Tromethamine Dispersible Tablet 10 mg) of Dr. Reddy’s
Laboratories Ltd., India in healthy, adult, human subjects under fed condition.
Total expected duration of the study will be of at least 10 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.
|