Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects

Bioequivalence Study Clinical Trial

Official title:

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595425
• Other study ID #: D961TC00001
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2012
• Last updated: December 11, 2012
• Start date: May 2012
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.

Description:

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study specific procedures

2. Japanese healthy male subjects aged 20 to 45 years of age

3. Body Mass Index 19-27 kg/m2 and body weight 50-85 kg

4. Clinically normal findings

5. Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19

Exclusion Criteria:

1. Significant clinical illness

2. Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease

3. Clinical significant condition which could modify the absorption of the investigational product

4. Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bioequivalence Study

Intervention

Drug:
• D961H Sachet 20 mg
Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days.
• D961H HPMC capsule 20 mg
Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days.

Locations

Country	Name	City	State
Japan	Research Unit	Fukuoka-shi	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt and Cmax,ss of D961H	AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration; Cmax,ss - maximum concentration at steady state	Day 5	No
Secondary	Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2.	AUC0-t,ss-Area under plasma concentration time curve from zero to time of the last measurable concentration at steady state; MRT- Mean residence time; tmax,ss -time of maximum concentration at steady state; t½ -Terminal half-life	Day 5	No
Secondary	Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature.		Up to 5 to 7 days after the last dose.	Yes
Secondary	Number of participants with adverse events.		Up to 5 to 7 days after the last dose.	Yes