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

NCT ID: NCT02659683

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-05-31

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test

Torrent's Esomeprazole Magnesium DR Capsules 40 mg

Group Type: EXPERIMENTAL

Torrent's Esomeprazole Magnesium DR Capsules 40 mg

Intervention Type: DRUG

oral, cross over

Reference

Nexium 40 mg DR Capsules of AstraZeneca LP, USA

Group Type: ACTIVE_COMPARATOR

Nexium 40 mg DR Capsules of AstraZeneca LP, USA

Intervention Type: DRUG

oral, cross over

Interventions

Nexium 40 mg DR Capsules of AstraZeneca LP, USA

oral, cross over

Intervention Type: DRUG

Torrent's Esomeprazole Magnesium DR Capsules 40 mg

oral, cross over

Intervention Type: DRUG

Other Intervention Names

esomeprazole magnesium delayed release capsules; esomeprazole magnesium delayed release capsules

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Torrent Pharmaceuticals Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PK-10-179

Identifier Type: -

Identifier Source: org_study_id