CTRI/2019/05/019483 [Registered on: 31/05/2019] Trial Registered Prospectively
Last Modified On:
22/06/2020
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Bioequivalence study of Betahistine Dihydrochloride Orally disintegrating strips
Scientific Title of Study
A Randomized,Open label, Balanced, Two Treatment, Two period, Two sequence, Single Dose,Crossover, Bioequivalence study of BetahistineDihydrochloride Orally disintegrating strip (ODS) 24 mg of Shilpa Therapeutics Pvt. Ltd (Co-developed by Abbott India Ltd.) with Vertin (Betahistine) 24 mg Tablets of Abbott India Ltd., in Normal, Healthy, Adult, Male and Female Human Subjects Under Fasting Conditions.
Trial Acronym
Betahistine ODS
Secondary IDs if Any
Secondary ID
Identifier
ARL/17/529 Version 2.0; 03-05-2019 Study Code: BETA1010
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr VandanaSahlam
Designation
Principal Investigator
Affiliation
Accutest Research Laboratories India Pvt. Ltd
Address
Clinical Department
A-31, MIDC, T.T.C. Industrial Area, Khairane, Navi Mumbai,Maharashtra, India
Thane MAHARASHTRA 400709 India
Phone
Fax
Email
Vandana.sahlam@accutestglobal.com
Details of Contact Person Scientific Query
Name
Dr VandanaSahlam
Designation
Principal Investigator
Affiliation
Accutest Research Laboratories India Pvt. Ltd
Address
Clinical Department
A-31, MIDC, T.T.C. Industrial Area, Khairane, Navi Mumbai,Maharashtra, India
Thane MAHARASHTRA 400709 India
Phone
Fax
Email
Vandana.sahlam@accutestglobal.com
Details of Contact Person Public Query
Name
Dr VandanaSahlam
Designation
Principal Investigator
Affiliation
Accutest Research Laboratories India Pvt. Ltd
Address
Clinical Department
A-31, MIDC, T.T.C. Industrial Area, Khairane, Navi Mumbai,Maharashtra, India
In each Period, single test IMP (24 mg ODS) will be placed on subjects tongue and will be allowed to disintegrate, swallowed the saliva and followed by 240 ml of water at ambient temperature as per the randomization schedule.
In each period subject will be housed 24 hours post dose.
To total study duration is approximately 10 days with a washout period is 7 days between each period
Comparator Agent
Vertin (Betahistine) 24 mg Tablets
In each period, single Reference IMP (24 mg Tablet) will be administered to subjects as per the randomization schedule.
In each period subject will be housed 24 hours post dose.
To total study duration is approximately 10 days with a washout period is 7 days between each period
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
1. Male and non-pregnant female human subjects, age in the range of 18 – 45 years both inclusive.
2. Body Mass Index between 18.5-30 Kg / m2 extremes included.
3. Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature).
4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry (including serum electrolytes), urinalysis, 12 lead ECG and chest X-ray (if done).
5. Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until after the last blood sample collection in each study period and adherence to food, fluid and posture restrictions.
6. No history of significant alcoholism.
7. No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs (Appendix B) for the last 06 months.
8. Nonsmokers as evident from the history obtained will be included.
ExclusionCriteria
Details
1. Known history of hypersensitivity to Betahistinedihydrochloride or related drugs.
2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
3. Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IMP.
4. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood–forming organs etc.
5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
6. Participation in a clinical drug study or bioequivalence study 90 days prior to period I dosing of the present study.
7. Subjects with any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism and elimination of drugs.
8. Subjects who in the opinion of the investigator should not participate in the study.
9. History of malignancy or other serious diseases.
10. Blood donation 90 days prior to period I dosing of the present study.
11. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
12. Found positive in breath alcohol test in each period.
13. Found positive in urine test for drug abuse in each period.
14. History of problem in swallowing.
15. Any contraindication to blood sampling.
16. Female subjects found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin) test.
17. Lactating women (currently breast feeding).
18. Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
19. Use of hormonal contraceptives either oral or implants.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To compare Cmax, AUC0-t and AUC0-inf of Test and Reference products
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This
is a Randomized, Open label, Balanced, Two Treatment, Two period, Two sequence,
Single Dose, Crossover, Bioequivalence study of Betahistine Dihydrochloride
Orally disintegrating strip (ODS) 24 mg of Shilpa Therapeutics Pvt. Ltd
(Co-developed by Abbott India Ltd.) with Vertin (Betahistine) 24 mg Tablets of
Abbott India Ltd., in Normal, Healthy, Adult, Male and Female Human Subjects Under
Fasting Conditions.