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Bioequivalence study of ALGOLIDER 100 mg granules (Nimesulide) with Aulin® 100 mg granules (Nimesulide)in healthy adult human subjects under fed conditions.

An Open label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral bioequivalence study of ALGOLIDER 100 mg granules (Nimesulide) of Fine Foods & Pharmaceuticals N.T.M. SpA, Italy with Aulin® 100 mg granules (Nimesulide) of ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO, Italy in healthy adult human subjects under fed conditions. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074010
Enrollment
24
Registered
2024-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

None listed

Interventions

Intervention1: ALGOLIDER 100 mg granules (Nimesulide): Name of the drug: ALGOLIDER 100 mg granules (Nimesulide), Route of administration: Oral, Frequency: single oral dose, Study duration:10 days. Con

Sponsors

EURO LIFECARE LTD
Lead Sponsor

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 18-45 years (both inclusive) of age. 4. Body mass index in the range of 18.5 – 30.0 kg/m2 (both inclusive). 5. 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 at the time screening as well as check-in and check-out during each study period.

Exclusion criteria

Exclusion criteria: 1. Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs. 2. History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 3. History of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. 4. History of hepatotoxic reactions to Nimesulide. 5. History of Concomitant exposure to other potentially hepatotoxic substances.

Design outcomes

Primary

MeasureTime frame
To evaluate Pharmacokinetics parameters: Cmax, AUC0-t and AUC0-8.Timepoint: From Day 01 to day 10—

Secondary

MeasureTime frame
To evaluate Pharmacokinetics parameters: Tmax, AUC_% Extrap_obs, ?z and t1/2.Timepoint: From Day 01 to day 10—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Private limited

harish@icbiocro.com08023641042

Outcome results

None listed

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