The Bioequivalence of Rasagiline Tablets in Chinese Healthy Subjects Under Fasting and Fed

108 healthy Chinese subjects participated in a randomized, crossover pharmacokinetic study comparing two rasagiline tablet formulations. Blood samples were collected up to 10 hours post-dose, and pharmacokinetic parameters like AUC and Cmax were measured using LC-MS/MS. The study concluded bioequivalence between the test and reference products under both fasting and high-fat postprandial conditions.

Use Cases

• Compare pharmacokinetic parameters (AUC, Cmax) between drug formulations based on the described study results.
• Model the effect of food intake (fasting vs. high-fat meal) on drug absorption using the described postprandial group data.
• Validate bioequivalence assessment methods using the reported geometric mean ratios and 90% confidence intervals.
• Analyze safety and tolerability profiles of rasagiline based on the reported adverse event data.

Strengths

• Data originates from a structured clinical trial with 108 subjects across fasting and postprandial groups.
• Pharmacokinetic parameters were measured with a specific analytical method (LC-MS/MS).
• Study design included a washout period and crossover sequence to control for individual variation.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment.
• Data may reflect geographic bias inherent to the single-site study in Chinese subjects.

Provenance

Source

Capital Medical University

Collection Method

Open, randomized, single-dose, double-cycle, two-sequence, self-crossover pharmacokinetic study.

Geography

China