A Three-Period Study to Investigate the Relative Bioavailability and Pharmacodynamic Profiles of a Zegerid 20mg Capsule, Zegerid 20mg Powder for Oral Suspension and Losec 20mg Capsule in Healthy Adult Volunteers Under Fasting Conditions

NCT01710995 | Completed Phase 1 DMC

• 1 other identifier: ZEG-02/2010 (BE)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder and Losec 20mg capsules in healthy volunteers under fasting conditions.

Conditions

Acid Reflux; Gastro Oesophageal Reflux Disease

Outcome Measures

Primary Outcomes (2)

• Bioavailability - Area under Curve of pH at 2 hours

  To assess the relative bioavailability of two immediate release formulations of omeprazole/sodium carbonate (Zegerid 20mg capsule and Zegerid 20mg powder for oral suspension)

  2 hours

• Pharmacodynamics - Area under Curve of pH at 2 hours

  To assess the relative pharmacodynamic profiles of two immediate release formulations of omeprazole/sodium bicarbonate (Zegerid® 20mg capsule and Zegerid® 20mg powder for oral suspension).

  2 hours

Secondary Outcomes (5)

• Safety and tolerability of study formulations using measurements of Cmax, tmax and t1/2

  pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose

• Bioavailability - measurement of pH over time

  0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours

• Bioavailability - measurement of pH over time

  0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours

• Pharmacodynamic Measurements of Cmax, Tmax and t1/2

  Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose

• Pharmacodynamic measurements of Cmax, Tmax and t1/2

  Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose

Study Arms (3)

Zegerid 20mg capsule

ACTIVE COMPARATOR

Zegerid 20mg capsule (20mg omeprazole and 1100mg sodium carbonate

Drug: Zegerid

Zegerid 20mg powder for oral suspension

ACTIVE COMPARATOR

Zegerid 20mg powder for oral suspension (20mg omeprazole and 1680mg sodium bicarbonate)

Drug: Zegerid

Losec 20mg capsule

ACTIVE COMPARATOR

Losec 20mg capsule (20mg omeprazole)

Drug: Losec

Interventions

Zegerid DRUG

Zegerid 20mg capsule; Zegerid 20mg powder for oral suspension

Losec DRUG

Losec 20mg capsule

Eligibility Criteria

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

You may qualify if:

• Healthy adult male or female volunteers aged 18 - 45 years.
• Non-smokers from three months before receiving the first dose and for the duration of the study, confirmed by negative urinary cotinine test at screening and check-in.
• Body mass index (BMI) ≥ 18.0 and ≤ 27.9 kg/m2.
• Able to voluntarily provide written informed consent to participate in the study.
• Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol.
• Able and willing to have a nasogastric tube/probe inserted.
• Females must be post-menopausal (for at least one year and confirmed by serum FSH at screening), surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository.
• Hormonal and IUD methods of contraception must be established for a period of three months prior to dosing and cannot be changed or altered during the study.
• Females of childbearing potential must have a negative pregnancy test at screening and check-in.
• Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
• The volunteer's primary care physician must confirm that there is nothing in their medical history that would preclude their enrolment into this clinical study.

You may not qualify if:

• Positive for HIV, hepatitis B or hepatitis C.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease as determined by the Investigator.
• History of gastric or duodenal ulcer.
• History of hiatus hernia.
• Significant history of reflux symptoms on clinical judgement.
• Diagnosis of conditions likely to result in a hypersecretory gastric acid state e.g. Zollinger-Ellison Syndrome.
• Positive serology test result for H. pylori at screening.
• Clinically significant deviated nasal septum or other nasopharyngeal obstruction, or inability to tolerate or site a nasogastric tube at screening.
• Hypersensitivity or any other contraindication to Zegerid® or Losec®.
• History or presence of any clinically significant drug allergy.
• Female subjects who are pregnant or lactating.
• Laboratory values at screening which are deemed to be clinically significant as determined by the Investigator.
• Any clinically relevant history of drug or alcohol abuse.
• Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.
• Participation in a clinical drug study during the 90 days preceding the initial dose of study medication.

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Bio-Kinetic Europe Limited, 14 Great Victoria Street, Belfast BT2 7BA

Belfast, BT2 7BA, United Kingdom

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

omeprazole, sodium bicarbonate drug combination; Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

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

• Jerome Hanna, MB BCH MRCS

  Bio-Kinetic Europe, Ltd.

  PRINCIPAL INVESTIGATOR

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: August 3, 2012
• First Posted: October 19, 2012
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: February 1, 2011
• Last Updated: October 19, 2012

Record last verified: 2012-10

Locations

GB (1)