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Stuy on the Variability of Agomelatine

Evaluation of the Highly Variable Agomelatine Pharmacokinetics in Chinese Healthy Subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-13003835
Enrollment
Unknown
Registered
2013-10-31
Start date
2012-09-14
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression

Interventions

4:a single oral dose of 25mg agomelatine

Sponsors

the Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
19 Years to 29 Years

Inclusion criteria

Inclusion criteria: Aged between 18 and 40 yearsinclusive; Good general health as a result of review of medical history and/or clinical testing at the time of screening; Available for the duration of the trial (4 weeks); Willingness to participate in the study as evidenced by signing the informed consent document, or by fingerprinting the consent document with the signature of a witness.

Exclusion criteria

Exclusion criteria: Subject is unwilling to use reliable contraception methods for the period of at least 2 months prior to first adminitration to 3 months after last administration; Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol;Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis; Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol; Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol;History of receiving any investigational product within the past 30 days; History of a severe allergic reaction or anaphylaxis; subjects confirm positive hepatitis B surface antigen (HBsAg), HIV-1, hepatitis C virus (HCV).

Design outcomes

Primary

MeasureTime frame
the intra-subject coefficience of variability is 43.52%;

Countries

China

Contacts

Public ContactGuoping Yang

the Third Xiangya Hospital, Central South University

ygp9880@126.com+86 0731-88618326

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 7, 2026