None listed
Conditions
Interventions
Intervention1: Fexofenadine Hydrochloride Oral Suspension: 180 mg/5 mL
Oral Dose
Three (each period one time)
Control Intervention1: Telfast Tablets: 180 mg
Oral Dose
Three (each period one time)
Sponsors
Mahashiv Limited
Spinos Lifescience and Research Private Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Bioavailability on Fexofenadine Hydrochloride Oral Suspension 180 mg/5 mL with Telfast tablets 180 mgTimepoint: 22 blood samples 00.00 hours, 00.25 hours, 00.50 hours, 00.75 hours, 01.00 hours, 01.25 hours, 01.50 hours, 01.75 hours, 02.00 hours, 02.33 hours, 02.67 hours, 03.00 hours, 03.50 hours, 04.00 hours, 04.50 hours, 05.00 hours, 06.00 hours, 08.00 hours, 10.00 hours, 12.00 hours, 16.00 hours and 24.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the palatability (Test Product) safety & tolerability of single dose administered in healthy adult human subjects under fasting conditionsTimepoint: 22 blood samples 00.00 hours, 00.25 hours, 00.50 hours, 00.75 hours, 01.00 hours, 01.25 hours, 01.50 hours, 01.75 hours, 02.00 hours, 02.33 hours, 02.67 hours, 03.00 hours, 03.50 hours, 04.00 hours, 04.50 hours, 05.00 hours, 06.00 hours, 08.00 hours, 10.00 hours, 12.00 hours, 16.00 hours & 24.00 hours | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and Research Private Limited
Outcome results
None listed