Phase I Study of BM2216 ER vs. Melogabalin Besilate: Safety, PK, and Food Effect in Healthy Adults
Summary
A Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, Food Effect, Single-Dose Proportionality, and Multiple-Dose Pharmacokinetic Comparison with Melogabalin Besilate Tablets after Single and Multiple Oral Administrations of BM2216 Extended-Release Tablets in Healthy Adult Subjects. To evaluate the pharmacokinetic characteristics of BM2216 Extended-Release Tablets in healthy adult subjects under fasting and postprandial conditions, and to assess the impact of food; to evaluate the dose proportionality following a single administration.To compare the single and multiple dose pharmacokinetic characteristics of BM2216 Extended-Release Tablets with those of Melogabalin Besilate Tablets, and to determine the relative bioavailability.To assess the safety of BM2216 Extended-Release Tablets in healthy adult subjects following single and multiple oral administrations.
Timeline
- Start
- 2024-12-01
- Primary completion
- 2025-01-04
- Completion
- 2025-01-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BM2216 | Unknown | 5.5 mg | Oral |
| Subject | BM2216 | Unknown | 11 mg | Oral |
| Subject | BM2216 | Unknown | 16.5 mg | Oral |
| Subject | BM2216 | Unknown | 33 mg | Oral |
| Subject | Mirogabalin | Small molecule | 15 mg | Oral |