NCT01170169

Brief Summary

This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fasting condition.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

Enrollment Period

2 months

First QC Date

May 31, 2010

Last Update Submit

July 26, 2010

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on Cmax and AUC parameters

    5 months

Study Arms (2)

Omeprazole

EXPERIMENTAL

Omeprazole Delayed Release Capsules of Dr. Reddy's laboratories limited

Drug: Omeprazole

Prilosec

ACTIVE COMPARATOR

Prilosec® 40 mg of Merck \& Co.Inc.

Drug: Prilosec

Interventions

OmeprazoleDRUG

Omeprazole Delayed Release Capsules 40 mg

Also known as: Prelosec 40 mg
Omeprazole
PrilosecDRUG

Prilosec® 40 mg of Merck \& Co.Inc.

Prilosec

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who provided written informed consent.
  • Subjects who were healthy within 18-45 years of age, weighing at least 50 kg.
  • Body mass index of ≥ 18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
  • Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I).
  • Subjects with normal ECG, chest X-ray (PA view) and vital signs.
  • Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
  • Test product, dose, mode of administration and batch number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Majoj K Bose

    Vimta Labs Limited, 142, IDA, Phase-II, Cherlapally, Hyderabad - India-500 051

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 31, 2010

First Posted

July 27, 2010

Study Start

January 1, 2006

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

July 27, 2010

Record last verified: 2010-07