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Comparative Pharmacokinetic Study of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Healthy Subjects

NCT06890715 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-03-24

No results posted yet for this study

Summary

A randomized, open-label, two-period, double-crossover comparative pharmacokinetic (PK) study of a single oral dose of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Chinese healthy subjects Primary objective: To evaluate the bioequivalence of the test product and the reference product by comparing their plasma concentrations and main PK parameters by oral administration in healthy Chinese subjects using Ramelteon Modified-Release Tablets (strength: 8 mg/tablet) developed by Overseas Pharmaceuticals, Ltd. as the test product and Ramelteon Tablets (trade name: Rozerem®, strength: 8 mg/tablet) produced by Takeda Pharmaceuticals America, Inc. as the reference product. Secondary objective: To evaluate the safety of Ramelteon Modified-Release Tablets (test product) and Ramelteon Tablets (reference product) with oral administration after drinking milk in healthy Chinese subjects.

Conditions

  • Chronic Insomnia Characterized

Interventions

DRUG

Test product (T): Ramelteon Modified-Release Tablets

Oral, take 1 tablet at a time, once a day.

DRUG

Reference product (R): Ramelteon Tablets

Oral, take 1 tablet at a time, once a day.

Sponsors & Collaborators

  • Beijing CTSmed Co. Ltd

    collaborator UNKNOWN

  • Overseas Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Shuai He Associate Chief Pharmacist, Doctor · The Zhujiang Hospital of Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2024-07-02
Completion
2024-07-08
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06890715 on ClinicalTrials.gov