An open label, balanced, randomized, two-treatment, twoperiod, two-sequence,single oral dose, crossover, bioequivalence study of Esomeprazole 20 mg & Naproxen 500 mg Delayed Release Tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) in comparison with Vimovo 20/500 mg Delayed Release Tablets (EsomeprazoleMagnesium 20 mg + Naproxen 500 mg) of AstraZeneca in healthy, adult, human subjects underfasting condition.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞
Study Overview
Brief Summary
STUDY TITLE:
An open label, balanced, randomized,two-treatment, two-period, two-sequence, single oral dose, crossover,bioequivalence study of Esomeprazole 20 mg &Naproxen 500 mg Delayed Release Tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) incomparison with Vimovo 20/500 mg Delayed ReleaseTablets (Esomeprazole Magnesium 20 mg + Naproxen 500 mg) of AstraZeneca in healthy, adult, human subjects underfasting condition.
OBJECTIVES:
Primary objective:
To compare the rate and extent of absorption of Esomeprazole 20 mg & Naproxen 500 mg DelayedRelease Tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) with that of Vimovo 20/500 mg Delayed Release Tablets (Esomeprazole Magnesium20 mg + Naproxen 500 mg) of AstraZeneca inhealthy, adult, human subjects under fasting condition.
Secondaryobjective:
Tomonitor the safety and tolerability of the study subjects after administrationof Esomeprazole Magnesium 20 mg + Naproxen 500 mg tablets in healthy, adult, human subjects underfasting condition
Number of subjects: Thirty two (32)
Duration of clinical study: 11 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
- •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 30 kg m2 both inclusive 5 Healthy volunteers who are clinically non anemic will be included as per the discretion of PI CI Physician.
Exclusion Criteria
- •1 Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood 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.
Outcomes
Primary Outcomes
To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞
Time Frame: From Day 01 to Day 11
Secondary Outcomes
- To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2(From Day 01 to Day 11)