Phase 1 Study of DS-3201b to Assess the Effects of Multiple Oral Administration of Rifampicin on the Pharmacokinetics of Single Oral Administration of DS-3201b Tablets in Healthy Japanese Subjects
Phase 1
Completed
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080225242
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. Gender: Japanese males or females
2. Age: >=20 and =<45 years (at the time of informed consent)
3. Body mass index (BMI) = Body weight (kg) / (Height [m])2: >=18.5 and <25.0 (at screening)
Exclusion Criteria
1. Having a history of hypersensitivity to any drugs or substances including rifampicin, or being idiosyncratic (eg, having penicillin allergy)
2. Having alcohol or drug dependence etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>- Pharmacokinetic parameters of plasma concentration of total DS-3201a: <br>Cmax, AUClast, AUCinf
- Secondary Outcome Measures
Name Time Method safety<br>Pharmacokinetic:<br>- Pharmacokinetic parameters of plasma concentration of total DS-3201a:<br>Tmax, Kel, t1/2, CL/F, Vz/F<br>- Pharmacokinetic parameters of plasma concentrations of unbound DS-3201a:<br>Cmax, AUClast, AUCinf, Tmax, Kel, t1/2<br>- Pharmacokinetic parameters of plasma concentration of total CALZ-1809a:<br>Cmax, AUClast, AUCinf, Tmax, Kel, t1/2<br>Safety:<br>Adverse events, laboratory tests, body weight, vital signs (blood pressure, pulse rate, body temperature), and 12-lead electrocardiogram