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

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

Tracking Information

• First Submitted Date: November 9, 2015
• First Posted Date: January 20, 2016
• Last Update Posted Date: February 3, 2016
• Study Start Date: May 2011
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Esomeprazole Magnesium DR Capsules Under Fasting Conditions
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy Subjects

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 15, 2016): 54
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2011
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02659683
• Other Study ID Numbers: PK-10-179
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Torrent Pharmaceuticals Limited
• Study Sponsor: Torrent Pharmaceuticals Limited
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Torrent Pharmaceuticals Limited
• Verification Date: November 2015