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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Torrent Pharmaceuticals Limited
• Treatments: Esomeprazole

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.