Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02659683
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : February 3, 2016
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg Phase 1

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Test
Torrent's Esomeprazole Magnesium DR Capsules 40 mg
Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg
oral, cross over
Other Name: esomeprazole magnesium delayed release capsules

Active Comparator: Reference
Nexium 40 mg DR Capsules of AstraZeneca LP, USA
Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA
oral, cross over
Other Name: esomeprazole magnesium delayed release capsules

Primary Outcome Measures :
  1. Cmax [ Time Frame: pre-dose to 20 hours post-dose ]
    Pharmacokinetic Evaluation

  2. AUC [ Time Frame: pre-dose to 20 hours post-dose ]
    Pharmacokinetic Evaluation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
Layout table for additonal information
Responsible Party: Torrent Pharmaceuticals Limited Identifier: NCT02659683    
Other Study ID Numbers: PK-10-179
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: November 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action