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

Healthy Subjects Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659683
• Other study ID #: PK-10-179
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2015
• Last updated: February 2, 2016
• Start date: May 2011
• Est. completion date: May 2011

Study information

• Verified date: November 2015
• Source: Torrent Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Nexium 40 mg DR Capsules of AstraZeneca LP, USA
oral, cross over
• Torrent's Esomeprazole Magnesium DR Capsules 40 mg
oral, cross over

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Torrent Pharmaceuticals Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Pharmacokinetic Evaluation	pre-dose to 20 hours post-dose	No
Primary	AUC	Pharmacokinetic Evaluation	pre-dose to 20 hours post-dose	No