Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsules Under Fasting Conditions

NCT01045642 | Completed Phase 1

• 1 other identifier: OMP/CR/070/0607
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR Capsules of Dr. Reddy's Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets) of Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Omeprazole; Crossover

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  4 months

Study Arms (2)

Prilosec 20 mg Tablets

ACTIVE COMPARATOR

Drug: Omeprazole

Omeprazole Magnesium DR 20 mg Capsules

EXPERIMENTAL

Drug: Omeprazole

Interventions

Omeprazole DRUG

Omeprazole Magnesium DR Capsules 20 mg

Also known as: Prilosec OTC 20 mg Tablets

Omeprazole Magnesium DR 20 mg Capsules; Prilosec 20 mg Tablets

Eligibility Criteria

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

You may qualify if:

• Subjects who provided written informed consent.
• Subjects who were healthy adults within 18-45 years of age (inclusive).
• Body mass index of ≥ 18 kg/m2 and ≤ 25 kglm2 with body weight not less than 50 kg.
• Subjects who had normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of Period-I.
• Had normal ECG, Chest X-ray and vital signs.
• Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
• If subject is a female volunteer and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device(IUD), or abstinence, or is postmenopausal for at least 1 year, or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
• Each female subject will be given a urine pregnancy test at check-in for period-I, period-II and post study.

You may not qualify if:

• Subjects incapable of understanding the informed consent.
• Subjects with BP≤90/60 mrn/Hg or BP≥140/90 mrn/Hg
• History of hypersensitivity or idiosyncratic reaction to Omeprazole or any other related drug.
• Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Subjects with a history of tuberculosis, epilepsy, asthma(during past 5 years),diabetes, psychosis or glaucoma will not be eligible for the study
• Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
• Subjects who has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past 30 days prior to dosing in Period-1.
• History of any psychiatric illness, which may impair the ability to provide written, informed consent.
• Subjects who have a history of alcohol or substance abuse within the last 5 years
• Subjects with clinically significant abnormal values of laboratory parameters.
• Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
• Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
• Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
• Subjects who are unable to or likely to be non-compliant with protocol requirements or restrictions.
• Any subject in whom Omeprazole is contraindicated for medical reasons
• Subjects who are intolerant to venipuncture

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Vimta Labs Limited

Hyderabad, Andhra Pradesh, 500 051, India

Location

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr IS Gandhi

  Vimta Labs Limited

  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: January 8, 2010
• First Posted: January 11, 2010
• Study Start: December 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: March 1, 2007
• Last Updated: January 20, 2010

Record last verified: 2010-01

Locations

IN (1)