To study the safety and bioavailability of Fexofenadine oral suspensio

Not Applicable

• Registration Number: CTRI/2024/07/070466
• Lead Sponsor: Mahashiv Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Normal healthy adult human subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 30.00 kg/m2

Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in

Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance

Generally healthy as documented by 12-lead electrocardiogram (ECG), Chest X-Ray and clinical laboratory assessments

Willing to consume Ovo lacto-vegetarian diet

Willing to comply to all requirements of this study protocol as well as instructed by the study personnel

Generally healthy as documented by gynaecological examination and breast examination

Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period

Exclusion Criteria

Evidence of allergy or known hypersensitivity to Fexofenadine Hydrochloride or its inactive ingredients

Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease

Any major illness in the last three months or any significant ongoing chronic medical illness

Any disease or condition which might compromise the haemopoeitic gastrointestinal hepatic renal cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis

History of alcohol addiction or abuse

Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study

Subject who had participated in any other study within the 90 days of check-in

History of difficulty in swallowing accessibility of veins

Positive results for urine screen of drugs of abuse alcohol test prior to check in

Study & Design

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