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

Torrent Pharma logo

Torrent Pharma

Status and phase

Completed
Phase 1

Conditions

Healthy

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

NCT02680132
PK-10-180

Details and patient eligibility

About

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.

Enrollment

56 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 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

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

56 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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