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BE of Torrent's Esomeprazole Mg DR Capsules

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ClinicalTrials.gov Identifier: NCT02680119
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited

Brief Summary:
Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Mg DR Capsule 1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 5 days.

Condition or disease Intervention/treatment Phase
Healthy 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 Mg DR Capsule containing Esomeprazole Mg 40 mg [ Test Formulation, Torrent Pharmaceutical Ltd., India] Versus Nexium 40 mg DR Capsule containing Esomeprazole 40 mg [Reference Formulation, AastraZeneca LP, USA] Under administered as the contents of capsule sprinkled over apple sauce in Healthy Human Volunteers Under Fasting Condition.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 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 Study of Esomeprazole Mg DR Capsule 40 mg [Torrent] Versus Nexium [AastraZeneca]- Sprinkled Over Apple Sauce in Subjects-Fasting 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, crossover
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, crossover
Other Name: esomeprazole magnesium delayed release capsules




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

  2. AUC [ Time Frame: Pre-dose to 20 hour post dose ]
    Pharmacokinetic Evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Responsible Party: Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT02680119     History of Changes
Other Study ID Numbers: PK-10-181
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action