Bioequivalence Study of Torrent Pharmaceutical Ltd’s Esomeprazole Magnesium Delayed Release Capsules


Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Delayed Release Capsule 1 × 40 mg and Nexium 1× 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 7 days.

Full Title of Study: “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-Fed Condition”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2011

Detailed Description

An Open Label, Randomized, 2 -Period, 2-Treatment, 2 Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Delayed Release Capsule 40 mg [Test Formulation, Torrent Pharmaceutical Ltd., India]Versus Nexium 40 mg Delayed Release Capsule containing Esomeprazole 40 mg. [Reference Formulation, AastraZeneca LP, USA] in Healthy Human Volunteers Under Fed Conditions.


  • Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA
    • oral, cross over
  • Drug: Torrent’s Esomeprazole Magnesium DR Capsules 40 mg
    • oral, cross over

Arms, Groups and Cohorts

  • Experimental: Test
    • Torrent’s Esomeprazole Magnesium DR Capsules 40 mg
  • Active Comparator: Reference
    • Nexium 40 mg DR Capsules of AstraZeneca LP, USA

Clinical Trial Outcome Measures

Primary Measures

  • Cmax
    • Time Frame: Pre dose to 24 hour post dose
    • Pharmacokinetic Evaluation
  • AUC
    • Time Frame: Pre dose to 24 hour post dose
    • Pharmacokinetic Evaluation

Participating in This Clinical Trial

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 35°C or more than 37.5°C. – 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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Torrent Pharmaceuticals Limited
  • Provider of Information About this Clinical Study
    • Sponsor

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