CTRI/2025/03/083410 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On:
10/03/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Comparative pharmacokinetic study of two different formulations of Olsalazine under fasting conditions in healthy adult volunteers.
Scientific Title of Study
An open-label, balanced, randomized, three-treatment, four-sequence, four-period, single dose, partial replicate, crossover, oral bioequivalence study of Test product 1 (T1), Olsalazine sodium 250 mg (250 mg x 2) capsules (Zuventus Healthcare Limited, India) and Test product 2 (T2), Olsalazine sodium 500 mg (500 mg x 1) capsules (Zuventus Healthcare Limited, India) with Reference product (R), Olsalazine Sodium 250 mg (250 mg x 2) capsules (Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom) in healthy, adult, human subjects under fasting conditions.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
AR023-23, (Ver. No. 2 dated: 01 Oct 2024)
Protocol Number
BE/ND/09/2024
DCGI
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Plot No. P-1 and P-2, IT-BT Park, Phase-II, MIDC, Hinjawadi, Pune (India)-411057
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Venkateshwarlu Yeldandi
ADVITY Research Pvt. Ltd.
3rd and 4th Floors, Archies Continental, P. No. 2A, 3, S. No. 1094 and 1095, Adj to Kukatpally Metro station, Kukatpally, Hyderabad 500072 Hyderabad TELANGANA
040-69089999
venkateshwarlu.y@advityresearch.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Vasavi Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy, adult, human subjects under fasting conditions
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Olsalazine Sodium 250 mg capsules (Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom)
1. Healthy adult human subjects between 18-45 years of age (including both)
2. Subjects are able to communicate effectively.
3. Voluntary participation.
4. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
5. Body mass index in the range of 18.5 to 29.9 kg/m² and weight equal to or more than 50 kgs.
6. Normal 12-lead ECG.
7. Normal chest X-ray.
8. Non-smokers and non-alcoholics.
9. Normal laboratory parameters.
10. Subject willing to abstain from all kinds of St John wort or grapefruit or citrus containing foods or juices from 07 days prior to admission until the last post dose blood sample collection in each study period and caffeine/xanthine containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) from 72.00 hours prior to admission until the last post dose blood sample collection in each study period.
11. Female subjects
of childbearing potential practicing an acceptable method of birth control for the duration of the study and willing to practice an acceptable method of birth control for 05 days after last dose as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence.
Or
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
ExclusionCriteria
Details
1. Volunteers with a known history of contraindication or hypersensitivity (e.g., anaphylaxis) to olsalazine or related class of drugs and any of its ingredients.
2. A history or presence of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs, severe, rarely fatal, anaphylactic-like reactions to NSAIDs, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological or psychiatric disease/disorder, dermatological, endocrine, immunological, hepatic impairment (such as Child-Pugh Class C), renal impairment, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
3. History or presence of gastrointestinal (GI) inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine
4. History or evidence of exfoliative dermatitis, Stevens Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
5. Any known enzyme inducing or inhibiting drug taken within 14 days before the study.
6. Participation in a drug research study within 90 days prior to dosing of this study.
7. Blood loss (more than 100 ml) or whole blood donation within 90 days prior to dosing.
8. A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
9. History of addiction to any recreational drug or drug dependence.
10. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g., fasting due to religious reasons.
11. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study admission of each study period.
12. Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the admission of each study period.
13. Positive results for alcohol consumption during the admission of each study period.
14. Intolerance to venipuncture.
15. Difficulty with donating blood.
16. Difficulty in swallowing investigational products.
17. Blood pressure on the day of admission of each study period.
18. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
19. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
20. Pulse rate less than 60 beats/minute or more than 100 beats/minute on the day of admission of each study period.
21. Use of any prescribed medication or OTC medicinal products including vitamins and herbal drugs within the 2 weeks or at least 5 half-lives of the compound whichever period is longer prior to commencement of the study.
22. History of alcohol abuse and/or dependence within six months of screening visit or History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study.
23. Females with positive results on serum pregnancy test.
24. Females currently breast-feeding.
25. Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used oral hormonal contraceptives within 14 days before dosing.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf of Olsalazine from the test product to that of reference product will be assessed.
Total Sample Size="28" Sample Size from India="28" 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
N/A
Date of First Enrollment (India)
31/03/2025
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="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
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
Olsalazine is a prodrug administered as an oral once-daily dose. It is converted to mesalamine in the colon, where it exerts its therapeutic effects by potentially reducing inflammation through the inhibition of cyclooxygenase and lipoxygenase pathways, thereby decreasing the production of pro-inflammatory mediators like prostaglandins. This study is designed to demonstrate the bioequivalence between the Test product (Olsalazine sodium 250 mg and 500 mg capsules) of Zuventus Healthcare Limited with the Reference product (Olsalazine sodium 250 mg capsules) of Atnahs Pharma UK Limited, United Kingdom in healthy, adult, human subjects under fasting conditions.