Open-Label, Phase I, Pharmacokinetic Studies in Healthy Chinese Subjects to Evaluate the Bioequivalence and Food Effect of a Novel Formulation of Abiraterone Acetate Tablets.
Zeying FengYaxin LiuYun KuangShuang YangJinlei LiLing YeJie HuangQi PeiYuanyuan HuangGuo-Ping YangPublished in: Drug design, development and therapy (2022)
These three Phase I trials showed that N-AbA and excipient SNAC had excellent linear pharmacokinetic characteristics. A single dose of N-AbA 300 mg was bioequivalent to R-AbA 1000 mg in healthy subjects under fasting conditions. Meanwhile, SNAC had no effect on the pharmacokinetics of prednisone and prednisolone. The effect of food on N-AbA was significantly lower than that on R-AbA.
Keyphrases
- transcription factor
- arabidopsis thaliana
- open label
- clinical trial
- drug delivery
- human health
- squamous cell carcinoma
- type diabetes
- blood glucose
- randomized controlled trial
- skeletal muscle
- risk assessment
- radiation therapy
- phase iii
- blood pressure
- study protocol
- phase ii study
- climate change
- case control
- double blind