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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA; Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg

• Registration Number: NCT02659683
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2015-11
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2016-01-15
• Study First Posted: 2016-01-20
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference	Nexium 40 mg DR Capsules of AstraZeneca LP, USA	Nexium 40 mg DR Capsules of AstraZeneca LP, USA
Test	Torrent's Esomeprazole Magnesium DR Capsules 40 mg	Torrent's Esomeprazole Magnesium DR Capsules 40 mg

Primary Outcome Measures

Name	Time	Method
Cmax	pre-dose to 20 hours post-dose	Pharmacokinetic Evaluation
AUC	pre-dose to 20 hours post-dose	Pharmacokinetic Evaluation