A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression
The purpose of this study is to evaluate the safety of PDC-1421 Capsule in healthy subject, find the effective adequate dose for the next stage of the study, and accumulate information of possible mechanism of its anti-depressive effect.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
|Official Title:||A Dose Escalation Phase I Study of PDC-1421 Capsule to Evaluate the Safety in Healthy Volunteers|
- Physical examination, Vital sign, ECG, Hematology, Blood chemistry, AEs/SAEs monitoring, C-SSRS [ Time Frame: observe for 72hr after taking drugs ] [ Designated as safety issue: Yes ]Safety endpoint is based on the measurement of physical examination, vital signs,laboratory data, Electrocardiograph(ECG), Columbia-Suicide Severity Rating Scale (C-SSRS) evaluation and number of adverse events(AEs) and serious adverse events (SAEs) during the study period.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.
Placebo Comparator: Placebo control
Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774045
|Taipei Veterans General Hospital||Recruiting|
|Taipei, Taiwan, 112|
|Contact: Hsien-Ming Wu 886-3-578-6976 ext 11 email@example.com|
|Contact: Yu-Han Lee 886-2-8751-8701 ext 22 firstname.lastname@example.org|
|Principal Investigator: Cheng-Ta Li, MD|
|Principal Investigator: Tung-Ping Su, M.D|
|Principal Investigator:||Cheng-Ta Li, MD||Taipei Veterans General Hospital, Taiwan|
|Principal Investigator:||Tung-Ping Su, M.D||Taipei Veterans General Hospital, Taiwan|