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.
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.
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. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Torrent Pharmaceuticals Limited |
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 |
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