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Bioequivalence study on Bilastine 10 mg and Montelukast 4 mg per 5ml oral suspension

An open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on Bilastine 10 mg and Montelukast 4 mg per 5ml oral suspension of Rivpra Formulation Pvt. ltd., in comparison with Bilafav-M Suspension 10mg/4mg per 5 ml (Bilastine 10 mg and Montelukast 4 mg) of Synokem Pharmaceuticals Ltd., in healthy, adult, human subjects under fasting conditions. - NIl

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048342
Enrollment
24
Registered
2022-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Bilastine 10 mg and Montelukast 4 mg per 5ml oral suspension: Single oral dose only one time. Control Intervention1: Bilafav-M Suspension 10mg/4mg per 5 ml (Bilastine 10 mg and Montelu

Sponsors

RIVPRA FORMULATION PVT LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in 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 18-45 years (both inclusive) of age. 4.Body mass index in the range of 18 â?? 30 kg/m2 5.Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician. 6.Normal health status as determined by medical history and physical examination by the PI/CI/Physician at the time of screening and vital signs

Exclusion criteria

Exclusion criteria: 1.Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs. 2.History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 3.History of severe infection or major surgery in the past 6 months. 4.History of Minor surgery or fracture within the past 3 months. 5.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. 6.Any major illness or hospitalization within 90 days prior to check-in of first period.

Design outcomes

Primary

MeasureTime frame
Cmax, AUC0-t and AUC0-â??Timepoint: From day 1 to day 4 after dosing—

Secondary

MeasureTime frame
Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: From day 1 to day 4 after dosing—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com9900111997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026