Bioequivalence study of Esomeprazole 20 mg Naproxen 500 mg Delayed Release Tablets in healthy adult human subjects under fasting condition

Active, not recruiting

Conditions: Fasting condition

Registration Number: CTRI/2023/04/051767

Lead Sponsor: Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited)

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 32

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.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-âˆž	From Day 01 to Day 11

Secondary Outcome Measures

Name	Time	Method
To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, Î»z and t1/2	From Day 01 to Day 11

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