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 mg Tablets (Ibuprofen 400 mg) of Famar A.V.E Anthoussa Plant Anthoussa in healthy, adult, human subjects under fasting conditions.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cmax and AUC0-t
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Cmax and AUC0-t
Time Frame: Day 01 - Day 09
Secondary Outcomes
- AUC0-∞, Tmax , AUC_%Extrap_obs, λz and t1/2(Day 01 - Day 09)