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

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ClinicalTrials.gov Identifier: NCT02659683
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited

Tracking Information
First Submitted Date  ICMJE November 9, 2015
First Posted Date  ICMJE January 20, 2016
Last Update Posted Date February 3, 2016
Study Start Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
  • Cmax [ Time Frame: pre-dose to 20 hours post-dose ]
    Pharmacokinetic Evaluation
  • AUC [ Time Frame: pre-dose to 20 hours post-dose ]
    Pharmacokinetic Evaluation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Esomeprazole Magnesium DR Capsules Under Fasting Conditions
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA
    oral, cross over
    Other Name: esomeprazole magnesium delayed release capsules
  • Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg
    oral, cross over
    Other Name: esomeprazole magnesium delayed release capsules
Study Arms  ICMJE
  • Experimental: Test
    Torrent's Esomeprazole Magnesium DR Capsules 40 mg
    Intervention: Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg
  • Active Comparator: Reference
    Nexium 40 mg DR Capsules of AstraZeneca LP, USA
    Intervention: Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2016)
54
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02659683
Other Study ID Numbers  ICMJE PK-10-179
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Torrent Pharmaceuticals Limited
Study Sponsor  ICMJE Torrent Pharmaceuticals Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Torrent Pharmaceuticals Limited
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP