Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Esomeprazole Magnesium DR Capsules Under Fasting Conditions

Study Overview
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Brief Summary
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Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Magnesium DR Capsules 40 mg and Nexium® 40 mg DR Capsules of AstraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 4 days.

Detailed Description
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An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Esomeprazole Magnesium DR Capsule containing Esomeprazole Magnesium 40 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Nexium® 40 mg DR Capsules containing Esomeprazole Magnesium 40 mg (Reference , AstraZeneca LP, USA) in Healthy Human Volunteers Under Fasting Condition.

Official Title
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An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Esomeprazole Mg DR Capsule 40 mg [Torrent,India] Versus Nexium 40 mg DR Capsule [ AastraZeneca LP, USA] in Healthy Subjects-Fasted Condition.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA
* Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sex: male Age: 18-45 years Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. Healthy and willing to participate in the study. Volunteer willing to adhere to the protocol requirements and to provide written informed consent. Non-smokers or smoker who smokes less than 10 cigarettes per day. Exclusion Criteria: Inability to communicate or co-operate. Administration of any study drug in the period 0 to 3 months before entry to the study, History of significant blood loss due to any reason, including blood donation in the past 3 months. Volunteers suffering from any chronic illness such as arthritis, asthma etc. History of pre-existing bleeding disorder. Clinically relevant abnormalities in the results of the laboratory screening evaluation. Clinically significant abnormal ECG or Chest X-ray. HIV, HCV, HBsAg positive volunteers. History of alcohol or drug abuse. History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study. Positive to Breath alcohol test. Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test. Systolic blood pressure less than 100 mmHg or more than 140 mmHg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°F or more than 98.6°F. Respiratory rate less than 12/minute or more than 20/minute. History of allergy to the test drug or any drug chemically similar to the drug under investigation. Recent History of kidney or liver dysfunction. Volunteers suffering from any psychiatric (acute or chronic) disorder. Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Torrent's Esomeprazole Magnesium DR Capsules 40 mg | Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg<br>* oral, cross over<br>* Other names: esomeprazole magnesium delayed release capsules;|
| Active Comparator: Reference<br>Nexium 40 mg DR Capsules of AstraZeneca LP, USA | Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA<br>* oral, cross over<br>* Other names: esomeprazole magnesium delayed release capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Pharmacokinetic Evaluation | pre-dose to 20 hours post-dose | 
| AUC | Pharmacokinetic Evaluation | pre-dose to 20 hours post-dose |