None listed
Conditions
Interventions
Intervention1: Bilastine 20 mg and Montelukast 10 mg tablet: Single oral dose of Bilastine 20 mg and Montelukast 10 mg tablet once in a day.
Control Intervention1: Bilasure M tablet (Bilastine 20 mg a
Sponsors
JANYA BIOCARE Pvt Ltd
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). 5.Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12.0 to 16.0 g/dL for female. 6.Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period. 7.With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no. 9.1). 8.With a normal or clinically non-significant 12-lead ECG. 9.With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies. 10. Non-smokers and willing to abstain from smoking or chewing any tobacco containing product at least 72.00 hours prior to dosing if have history of smoking habit and throughout the sampling points.
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. 5.History of severe infection or major surgery in the past 6 months. 6.History of Minor surgery or fracture within the past 3 months. 7.Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction. 8.Any major illness or hospitalized within 90 days prior to the first dosing. 9.Any other clinical condition like diarrhea or vomiting within three days prior to dosing. 10.Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during the four weeks before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare rate and extend of orally administered molecule to prove bioequivalence on Bilastine 20 mg and Montelukast 10 mg tablet of JANYA BIOCARE Pvt. Ltd. Versus Bilasure M tablet (Bilastine 20 mg and Montelukast 10 mg) Manufactured by Hetero Labs Limited and marketed by Sun Pharmaceutical Industries Ltd., in healthy adult human subjects under fasting conditions.Timepoint: From Day 1 to Day 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the study subjects after administration of Bilastine and Montelukast tablet in healthy adult human subjects under fasting conditions.Timepoint: From Day 1 to Day 12 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed