Bioequivalence study of Ibuprofen 400 mg tablets of Pinnacle Life Science Pvt. Ltd., in healthy, adult, human subjects.

Active, not recruiting

• Conditions: Fasting condition

• Registration Number: CTRI/2023/05/052877
• Lead Sponsor: Pinnacle Life Science Pvt. Ltd.

Brief Summary

Study Title: An open label, balanced, randomized,two-treatment, two-period, two-sequence, single oral dose, crossover,bioequivalence study of Ibuprofen 400 mg tablets of Pinnacle Life Science Pvt.Ltd., In comparison with Brufen® 400 mgTablets (Ibuprofen 400 mg) of Famar A.V.E Anthoussa Plant Anthoussa inhealthy, adult, human subjects under fasting  conditions.

Study Objectives:

*Primaryobjective:*

To compare the rate and extent of absorption of Ibuprofen400 mg tablets of Pinnacle Life Science Pvt. Ltd., withthat of with Brufen® 400 mg Tablets (Ibuprofen400 mg) of Famar A.V.E Anthoussa Plant Anthoussa in healthy, adult, humansubjects under fasting conditions.

*Secondary objective:*

Tomonitor the safety and tolerability of the study subjects after administrationof Ibuprofen 400 mg tablets under fasting conditions.



Study Duration: 09 Days

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-26
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study.
• Willing to be available for the entire study period and to comply with protocol requirements.
• Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
• Body mass index in the range of 18.5 – 30 kg/m2 (both inclusive).

Exclusion Criteria

• Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–forming organs.
• History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
• History of severe infection or major surgery in the past 6 months.
• History of Minor surgery or fracture within the past 3 months.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax and AUC0-t	Day 01 - Day 09

Secondary Outcome Measures

Name	Time	Method
AUC0-∞, Tmax , AUC_%Extrap_obs, λz and t1/2	Day 01 - Day 09

Trial Locations

Locations (1)

ICBio Clinical Research Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

ICBio Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Priya R

Principal investigator

9900111997

pi.mail@icbiocro.com