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Bioequivalence study on Bilastine 20 mg and Montelukast 10 mg tablet of Rivpra Formulation Pvt. ltd., in healthy, adult, human subjects under fasting conditions.

An open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on Bilastine 20 mg and Montelukast 10 mg tablet of Rivpra Formulation Pvt. ltd., in comparison with BILAFAV M Tablet (Bilastine 20 mg and Montelukast 10 mg) of Hetero Labs Ltd in healthy, adult, human subjects under fasting conditions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054207
Enrollment
24
Registered
2023-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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 20 mg and Montelukast 10 mg tablet: Dose: 20 mg & 10 mg, Dosage form: Tablet, Frequency: single oral dose, Study duration: 11 days. Control Intervention1: BILAFAV M Tablet (Bi

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 18.5 â?? 30 kg/m2 (both inclusive).

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.

Design outcomes

Primary

MeasureTime frame
Cmax, AUC0-t and AUC0-â??Timepoint: From Day-01 to Day-11—

Secondary

MeasureTime frame
Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: From Day-01 to Day-11—

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