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

NCT02680132 | Completed Phase 1

• 1 other identifier: PK-10-180
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax

  Pharmacokinetic Evaluation

  Pre dose to 24 hour post dose

• AUC

  Pharmacokinetic Evaluation

  Pre dose to 24 hour post dose

Study Arms (2)

Test

EXPERIMENTAL

Torrent's Esomeprazole Magnesium DR Capsules 40 mg

Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg

Reference

ACTIVE COMPARATOR

Nexium 40 mg DR Capsules of AstraZeneca LP, USA

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

Interventions

Nexium 40 mg DR Capsules of AstraZeneca LP, USA DRUG

oral, cross over

Also known as: esomeprazole magnesium delayed release capsules

Reference

Torrent's Esomeprazole Magnesium DR Capsules 40 mg DRUG

oral, cross over

Also known as: esomeprazole magnesium delayed release capsules

Test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 11, 2016
• Study Start: May 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 11, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share