Bioequivalence study of Betahistine Dihydrochloride Orally disintegrating strips

Phase 1

Completed

• Conditions: Healthy Adult Male and Female Human Subjects

• Registration Number: CTRI/2019/05/019483
• Lead Sponsor: Shilpa Therapeutics Pvt Ltd

Brief Summary

Thisis a Randomized, Open label, Balanced, Two Treatment, Two period, Two sequence,Single Dose, Crossover, Bioequivalence study of Betahistine DihydrochlorideOrally disintegrating strip (ODS) 24 mg of Shilpa Therapeutics Pvt. Ltd(Co-developed by Abbott India Ltd.) with Vertin (Betahistine) 24 mg Tablets ofAbbott India Ltd., in Normal, Healthy, Adult, Male and Female Human Subjects UnderFasting Conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-17
• Study Completion: 2019-07-18
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Male and non-pregnant female human subjects, age in the range of 18 – 45 years both inclusive.
• Body Mass Index between 18.5-30 Kg / m2 extremes included.
• Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature).
• Subjects with clinically acceptable findings as determined by haemogram, biochemistry (including serum electrolytes), urinalysis, 12 lead ECG and chest X-ray (if done).
• 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.
• No history of significant alcoholism.
• No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs (Appendix B) for the last 06 months.
• Nonsmokers as evident from the history obtained will be included.

Exclusion Criteria

• Known history of hypersensitivity to Betahistinedihydrochloride or related drugs.
• Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
• Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IMP.
• Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood–forming organs etc.
• History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
• Participation in a clinical drug study or bioequivalence study 90 days prior to period I dosing of the present study.
• Subjects with any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism and elimination of drugs.
• Subjects who in the opinion of the investigator should not participate in the study.
• History of malignancy or other serious diseases.
• Blood donation 90 days prior to period I dosing of the present study.
• Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
• Found positive in breath alcohol test in each period.
• History of problem in swallowing.
• Any contraindication to blood sampling.
• Female subjects found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin) test.
• Lactating women (currently breast feeding).
• 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.
• Use of hormonal contraceptives either oral or implants.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare Cmax, AUC0-t and AUC0-inf of Test and Reference products	Pre-dose, 0.083, 00.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hrs post dose.

Secondary Outcome Measures

Name	Time	Method
AUC0-t/AUC0-inf, Residual area, Tmax, Kel and t1/2	Pre-dose, 0.083, 00.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hrs post dose.

Trial Locations

Locations (1)

Accutest Research Laboratories (I) Pvt. Ltd; 🇮🇳 Thane, MAHARASHTRA, India

Accutest Research Laboratories (I) Pvt. Ltd

🇮🇳Thane, MAHARASHTRA, India

Dr Vandana Sahlam

Principal investigator

02227780718

Vandana.sahlam@accutestglobal.com