BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects

NCT01964131 | Completed Phase 1

• 1 other identifier: D961TC00004
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH\>4. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH\>3 during 24 hours and 24-hour median pH. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.

Conditions

Gastric Ulcer; Duodenal Ulcer; Anastomotic Ulcer; Reflux Esophagitis; Etc.

Keywords

Bioequivalence; pharmacodynamics; pharmacokinetics; safety; tolerability; D961H; Japanese

Outcome Measures

Primary Outcomes (1)

• Description of whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg

  To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH\>4 during 24 hours after dose on Day 5.

  27 days

Secondary Outcomes (3)

• Description to compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH

  27 days

• Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.

  27 days

• Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.

  34 days

Study Arms (2)

D961H sachet 20 mg

EXPERIMENTAL

Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) and excipient granules filled into single-use aluminium sachets

Drug: D961H sachet 20 mg

D961H HPMC capsule 20 mg

OTHER

Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) in HPMC capsule

Drug: D961H HPMC capsule 20 mg

Interventions

D961H sachet 20 mg DRUG

Each subject will be randomised evenly to one of "Treatment: A--\>B (Sequence 1)" or "Treatment: B--\>A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg

D961H sachet 20 mg

D961H HPMC capsule 20 mg DRUG

Each subject will be randomised evenly to one of "Treatment: A--\>B (Sequence 1)" or "Treatment: B--\>A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg

D961H HPMC capsule 20 mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Healthy Japanese male subjects between 20 and 45 years of age
• Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
• Body weight 50-85 kg
• Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis
• Clinically normal findings at the enrolment medical examination, as judged by the investigator(s)
• Homo-EM according to the genotype of CYP2C19
• Less than 30% of time with intragastric pH\>4 during the baseline (pre-entry) 24-hr intragastric pH recording
• Helicobacter pylori negative has been known by urea breath test as the volunteer panel data

You may not qualify if:

• Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention
• Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
• Past or present drug addiction or alcohol abuse
• Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention
• Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use)
• Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach
• Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation)
• Need for concomitant medication in the study
• Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor
• Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1
• Administration of any investigational product within 4 months preceding the pre-entry visit
• Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site)
• Clinical judgment by the investigator(s) that the subject should not participate in the study

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Hakata Clinic Medical Co. LTA

Fukuoka, Fukuoka, 812-0025, Japan

Location

Research Site

Fukuoka, Fukuoka, Japan

Location

MeSH Terms

Conditions

Stomach Ulcer; Duodenal Ulcer; Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Esophagitis; Esophageal Diseases; Gastroenteritis

Study Officials

• Megumi Inoue, MD, PhD

  Hakata Clinic Medical Co. LTA

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 17, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

JP (2)