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

Torrent Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA

Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02659683

PK-10-179

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.