Bioequivalence Study of Torrent Pharmaceutical Ltd's Esomeprazole Magnesium Delayed Release Capsules

Torrent Pharma logo

Torrent Pharma

Status and phase

Phase 1




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

Study type


Funder types




Details and patient eligibility


Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Delayed Release Capsule 1 × 40 mg and Nexium 1× 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 7 days.

Full description

An Open Label, Randomized, 2 -Period, 2-Treatment, 2 Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Delayed Release Capsule 40 mg [Test Formulation, Torrent Pharmaceutical Ltd., India]Versus Nexium 40 mg Delayed Release Capsule containing Esomeprazole 40 mg. [Reference Formulation, AastraZeneca LP, USA] in Healthy Human Volunteers Under Fed Conditions.


56 patients




18 to 45 years old


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 35°C or more than 37.5°C.
  • 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.

Trial design

Primary purpose




Interventional model

Crossover Assignment


None (Open label)

56 participants in 2 patient groups

Experimental group
Torrent's Esomeprazole Magnesium DR Capsules 40 mg
Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg
Active Comparator group
Nexium 40 mg DR Capsules of AstraZeneca LP, USA
Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA

Trial contacts and locations



Data sourced from

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