A Randomised, Double-Blind, Placebo-Controlled, Two-Sequence, Two-Period, Crossover Study to Evaluate the Effect of SMP-028 on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
Completed
- Conditions
- asthmachronic inflammation of the lungs10006436
- Registration Number
- NL-OMON34656
- Lead Sponsor
- Dainippon Sumitomo Pharma Europe Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
healthy females
18-45 year
Exclusion Criteria
Clinical significant abnormalities for medical examination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics Microgynon</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetics SMP-028<br /><br>Pharmacodynamics<br /><br>Safety and tolerability</p><br>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does SMP-028 modulate CYP450 enzyme activity affecting oral contraceptive metabolism in healthy females?
What are the comparative pharmacokinetic interactions between SMP-028 and common CYP3A4 substrates like ethinyl estradiol?
Do CYP2C19 polymorphisms predict variable contraceptive efficacy when co-administered with SMP-028 in NL-OMON34656?
What adverse events are associated with SMP-028-contraceptive combinations in Dainippon Sumitomo Pharma's asthma trials?
How does SMP-028's mechanism compare to other PDE4 inhibitors in managing chronic lung inflammation and drug interactions?