- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02659683
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Esomeprazole Magnesium DR Capsules Under Fasting Conditions
February 2, 2016 updated by: Torrent Pharmaceuticals Limited
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.
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test
Torrent's Esomeprazole Magnesium DR Capsules 40 mg
|
oral, cross over
Other Names:
|
Active Comparator: Reference
Nexium 40 mg DR Capsules of AstraZeneca LP, USA
|
oral, cross over
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: pre-dose to 20 hours post-dose
|
Pharmacokinetic Evaluation
|
pre-dose to 20 hours post-dose
|
AUC
Time Frame: pre-dose to 20 hours post-dose
|
Pharmacokinetic Evaluation
|
pre-dose to 20 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
November 9, 2015
First Submitted That Met QC Criteria
January 15, 2016
First Posted (Estimate)
January 20, 2016
Study Record Updates
Last Update Posted (Estimate)
February 3, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PK-10-179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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