Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
Study NCT ID:
NCT06846567
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2025-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Study of BM2216 ER vs. Melogabalin Besilate: Safety, PK, and Food Effect in Healthy Adults
Sponsor:
Zhejiang Anglikang Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
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.--Single-Center, Randomized, Open-Label, Parallel/Crossover Design.
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This study is divided into three parts: PART-1, PART-2, and PART-3. It is planned that PART-2 will prioritize enrollment (all dose groups can be enrolled simultaneously), while PART-1 and PART-3 can also be enrolled concurrently. The doses for PART-1 and PART-3 may be adjusted based on the results of PART-2.
PART-1 (FE + Single-Dose PK Comparison):
A Single-Center, Randomized, Open-Label, Three-Period, Three-Sequence, Three-Way Crossover Study to Evaluate the Pharmacokinetic Characteristics and Food Effect of BM2216 Extended-Release Tablets After Single Oral Administration Under Fasting and High-Fat Meal Conditions in Healthy Adult Subjects, and to Compare the Pharmacokinetic Characteristics with Multiple-Dose Melogabalin Besilate Tablets, Relative Bioavailability, and Safety. This study plans to enroll 18 subjects, who will be randomly assigned to three dosing sequence groups in a 1:1:1 ratio.
PART-2 (Single-Dose Proportionality):
A single-center, open-label, parallel design will be used to evaluate the pharmacokinetic characteristics, dose proportionality, and safety of BM2216 extended-release tablets after a single dose in healthy adult subjects. This study plans to enroll 32 subjects, with four dose groups of BM2216 extended-release tablets (5.5 mg, 11 mg, 16.5 mg, and 33 mg), with 8 subjects in each group.
PART-3 (Multiple-Dose PK Comparison):
This study adopts a single-center, randomized, open-label, two-period, two-sequence, two-crossover design to evaluate the pharmacokinetic characteristics of BM2216 extended-release tablets after multiple oral doses in healthy adult subjects, as well as the pharmacokinetic comparison with multiple doses of mirogabalin besylate tablets, relative bioavailability, and safety. The study plans to enroll 16 subjects, who will be randomly assigned to two dosing sequence groups in a 1:1 ratio.
PART-1 (FE + Single-Dose PK Comparison):
A Single-Center, Randomized, Open-Label, Three-Period, Three-Sequence, Three-Way Crossover Study to Evaluate the Pharmacokinetic Characteristics and Food Effect of BM2216 Extended-Release Tablets After Single Oral Administration Under Fasting and High-Fat Meal Conditions in Healthy Adult Subjects, and to Compare the Pharmacokinetic Characteristics with Multiple-Dose Melogabalin Besilate Tablets, Relative Bioavailability, and Safety. This study plans to enroll 18 subjects, who will be randomly assigned to three dosing sequence groups in a 1:1:1 ratio.
PART-2 (Single-Dose Proportionality):
A single-center, open-label, parallel design will be used to evaluate the pharmacokinetic characteristics, dose proportionality, and safety of BM2216 extended-release tablets after a single dose in healthy adult subjects. This study plans to enroll 32 subjects, with four dose groups of BM2216 extended-release tablets (5.5 mg, 11 mg, 16.5 mg, and 33 mg), with 8 subjects in each group.
PART-3 (Multiple-Dose PK Comparison):
This study adopts a single-center, randomized, open-label, two-period, two-sequence, two-crossover design to evaluate the pharmacokinetic characteristics of BM2216 extended-release tablets after multiple oral doses in healthy adult subjects, as well as the pharmacokinetic comparison with multiple doses of mirogabalin besylate tablets, relative bioavailability, and safety. The study plans to enroll 16 subjects, who will be randomly assigned to two dosing sequence groups in a 1:1 ratio.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: