Phase I study of KRP-AM1977X (Clinical pharmacologyical study)

Phase 1

Completed

• Conditions: Healthy volunteers

• Registration Number: JPRN-jRCT2080222510
• Lead Sponsor: Kyorin Pharmaceutical Co.,LTD

Brief Summary

Geometric mean ratios (90%CI) of Cmax and AUC0-10 of theophylline when KRP-AM1977X was co-administered compared to theophylline alone were as follows: Day8; Cmax 1.09(0.94 to 1.28) and AUC0-10 1.10(0.95 to 1.28), Day 11; Cmax 1.17(1.01 to 1.35) and AUC0-10 1.18(1.02 to 1.37). The 90% confidence intervals for these geometric mean ratios were not within the reference range of no drug interaction (0.80-1.25). No major safety problem were observed when co-administered KRP-AM1977X and theophylline.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-23
• Study Completion: 2014-06-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

Japanese healthy adult male
- Person with BMI that is more than 18.5 but less than 25.0, etc.

Exclusion Criteria

- Healthy volunteer with a medical history, surgergical history and disease that are unsuitable for clinical trials
- An excessive drinker or a person who cannot stop drinking during a rule period, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pharmacokinetics<br>Pharmacokinetics<br>The concentration of theophylline in the blood plasma, etc.

Secondary Outcome Measures

Name	Time	Method
safety<br>Safety, etc<br>Adverse events and side effects, etc.