None listed
Conditions
Interventions
Intervention1: Bilastine 20 mg and Montelukast 10 mg tablet: Single oral dose one time during the study period for one day
Control Intervention1: Bilasure M tablet (Bilastine 20 mg and Montelukast 10
Sponsors
Signature Phytochemical Industries
Eligibility
Inclusion criteria
Inclusion criteria: 1.Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study. 2.Willing to be available for the entire study period and to comply with protocol requirements. 3.Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age. 4.Body mass index in the range of 18 â??30 kg/m2 (both inclusive)
Exclusion criteria
Exclusion criteria: 1.Found Positive (+Ve) on Rapid antigen test for COVID-19 during screening. 2.Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women. 3.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and bloodâ??forming organs. 4.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t and AUC0-â??Timepoint: from day 1 to 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: from day 1 to 12 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed