CTRI/2025/09/095146 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On:
26/11/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Bioequivalence study of Fexofenadine Hydrochloride 30 mg Chewable Tablet in healthy adult human participants.
Scientific Title of Study
An open-label, randomized, full replicate, two-treatment, four-sequence, four-period, crossover balanced, single dose oral bioequivalence study comparing a new Fexofenadine Hydrochloride 30 mg Chewable Tablet to the marketed Telfast® (Fexofenadine Hydrochloride) 30 mg film-coated tablet in healthy adult human participants under fasting conditions
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: C1B05679 Version: 01 Date: 28 Jun 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dhruv Patel
Designation
Senior Manager - Clinic
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
2717698500
Fax
Email
dppatel@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Manish Singhal
Designation
Director - Clinic
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
2717698500
Fax
Email
msinghal@cliantha.com
Details of Contact Person Public Query
Name
Dr Dhruv Patel
Designation
Senior Manager - Clinic
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
2717698500
Fax
Email
dppatel@cliantha.com
Source of Monetary or Material Support
NIL
Primary Sponsor
Name
Opella Healthcare Group SAS
Address
157 Avenue Charles de Gaulle, 92200 Neuilly-sur-Seine, France
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Cliantha Research Limited
Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Dhruv Patel
Cliantha Research Limited
Fourth Floor, Clinic Room, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India
Ahmadabad GUJARAT
Fexofenadine Hydrochloride 30 mg Chewable Tablet – Manufactured by: Opella Healthcare International SAS, 56 Route De Choisy 60200 Compiègne, France.
(Single dose) One tablet of test product Fexofenadine Hydrochloride 30 mg Chewable Tablet will be placed over the tongue of the participants as per the randomization schedule in a sitting posture. Participants will be instructed to completely chew the tablets, and then swallow the entire contents without water under the supervision of trained study personnel.
(Single dose) One tablet of reference product Telfast® (Fexofenadine Hydrochloride) 30 mg film-coated tablet will be administered orally to the participants as per the randomization schedule in a sitting posture with about 240 mL of water at ambient temperature in each period under the supervision of trained study personnel.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
55.00 Year(s)
Gender
Both
Details
1. Age: 18 to 55 years old, both inclusive.
2. Gender: Male and/or non-pregnant, non-lactating female.
A. Female of child-bearing potential must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test performed within 28 days of the first dose of study medication. They must be using an acceptable form of contraception.
B. For female of childbearing potential, acceptable forms of contraception include the following:
i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
ii. Barrier methods containing or used in conjunction with a spermicidal agent, or
iii. Surgical sterilization or
iv. Practicing sexual abstinence throughout the course of the study.
C. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
i. Postmenopausal with spontaneous amenorrhea for at least one year, or
ii. Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level greater than 40 mIU/mL, or
iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
iv. Total hysterectomy and an absence of bleeding for at least 3 months.
3. BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
4. Male participant having body weight greater than or equals to 50 Kg and less than or equals to 100 Kg both inclusive and female participant having body weight greater than or equals to 40 Kg and less than or equals to 90 Kg both inclusive.
5. Participant having normal vital signs after 10 minutes resting in supine position:
A. 95 mmHg less than systolic blood pressure (SBP) less than 140 mmHg
B. 45 mmHg less than diastolic blood pressure (DBP) less than 90 mmHg
C. 50 bpm less than heart rate (HR) less than 100 bpm
6. Participant having a normal or no clinically significant finding in 12-lead electrocardiogram (ECG) recording in supine position in the following ranges: 120 ms less than PR less than 220 ms, QRS less than 120 ms, QTc less than or equals to 450 ms if male, less than or equals to 470 ms. if female and normal ECG tracing unless an ECG tracing abnormality considered to be not clinically relevant.
7. Able to communicate effectively with study personnel.
8. Willing to provide written informed consent to participate in the study.
9. Not under any administrative or legal supervision.
10. All volunteers must be judged by the principal or sub investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of study medication administration which will include:
a. A physical examination (clinical examination) with no clinically significant finding.
b. Results within normal limits or clinically non-significant for the following tests:
the following tests:
1. Hematology
a. Hemoglobin b. Total RBC count c. Total WBC count d. Platelet count
A. Differential leukocyte count:
a. Neutrophils b. Lymphocytes c. Eosinophils d. Monocytes e. Basophils
B. Blood indices: HCT
2. Biochemistry
a. BUN b. Serum creatinine c. Random glucose d. SGPT and SGOT e. Alkaline phosphatase f. Uric acid g. Serum bilirubin
A. Serum total protein: Total proteins, Albumin
B. Serum electrolytes: Serum sodium, serum chloride, serum potassium, serum phosphorous, serum calcium
3. Urinalysis: Color, quantity, specific gravity, odour, appearance, reaction, albumin, bilirubin, ketone bodies, sugar, urobilinogen and microscopical examination (performed based on clinical judgment)
4. Immunological Tests
a. HIV-I and II b. HbsAg c. Anti HCV
5. Serum (beta-HCG) pregnancy test (for female of child-bearing potential)
6. Serum Follicular Stimulating Hormone (FSH) (if required)
a. Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion.
b. All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.
ExclusionCriteria
Details
1. History of allergic responses to Fexofenadine Hydrochloride or other related drugs, or any of its formulation ingredients.
2. Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female participants)].
3. Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
4. History or presence of bronchial asthma.
5. Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
6. Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
7. Use of CYP and/or P-gp enzyme inhibitors or inducers within 30 days prior to the first dose of study medication.
8. History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
9. Smoker who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
10. History of difficulty with donating blood or difficulty in accessibility of veins.
11. A positive hepatitis screen (includes subtypes B and C).
12. A positive test result for HIV antibody.
13. Participant who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
14. Participant who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or greater than 200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
15. History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
16. Intolerance to venipuncture
17. Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub investigator, could contraindicate the participants participation in this study.
18. Institutionalized participant.
19. Use of any prescribed medications (including ketoconazole, erythromycin, aluminum and magnesium containing antacids or any other antacid) within 14 days prior to the first dose of study medication.
20. Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
21. Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
22. Use of citrus fruits or fruit juices containing citrus, seville orange, starfruit, pomegranate, apple, pineapple, or pomelo within 7 days prior to the first dose of study medication.
23. Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), cigarettes and tobacco containing products, recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of study medication.
24. Use of products containing St. Johns wort within 14 days prior to the first dose of study medication.
25. Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
26. Participants having difference in systolic blood pressure (greater than or equals to 20 mmHg) or diastolic blood pressure (greater than or equals to 10 mmHg) when measured supine and standing blood pressure prior to check-in period-I.
27. Any participant who cannot be contacted in case of emergency.
28. Participant who have received any vaccination and any biologics (antibody or its derivatives) within the last 28 days prior to the first dose of study medication
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To determine the bioequivalence between the new Fexofenadine Hydrochloride 30 mg Chewable Tablet and the Telfast® (Fexofenadine Hydrochloride) 30 mg film-coated tablet
Pharmacokinetics blood sampling:
Pre-dose (0.0 hour) and at 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0 and 48.0 hours post dose (Approx. 0.3 Week)
Secondary Outcome
Outcome
TimePoints
To assess the clinical safety of the new Fexofenadine Hydrochloride 30 mg Chewable Tablet and Telfast® (Fexofenadine Hydrochloride) 30 mg film-coated tablet
48.0 hours post dose (Approx. 0.3 Week)
Target Sample Size
Total Sample Size="100" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "100" Final Enrollment numbers achieved (India)="100"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
An open-label, randomized, full replicate, two-treatment, four-sequence, four-period, crossover balanced, single dose oral bioequivalence study comparing a new Fexofenadine Hydrochloride 30 mg Chewable Tablet to the marketed Telfast (Fexofenadine Hydrochloride) 30 mg film-coated tablet in healthy adult human participants under fasting conditions
Objectives:
1. To determine the bioequivalence between the newFexofenadine Hydrochloride 30 mg Chewable Tabletand theTelfast (Fexofenadine Hydrochloride) 30 mg film-coated tablet.
2. To assess the clinical safety of the new Fexofenadine Hydrochloride 30 mg Chewable Tablet and Telfast (Fexofenadine Hydrochloride) 30 mg film-coated tablet.