Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-20 @ 7:01 AM
Study NCT ID:
NCT01880502
Status:
COMPLETED
Last Update Posted:
2013-10-14
First Post:
2013-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Belviq in Adult Korean Volunteers
Sponsor:
IlDong Pharmaceutical Co Ltd
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study (Phase I) to Evaluate the Tolerability and Pharmacokinetics of Belviq in Adult Korean Volunteers
Status:
COMPLETED
Status Verified Date:
2013-10
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 randomized, double-blind, placebo-controlled, single-dose, dose escalation study (Phase I) to evaluate the tolerability and pharmacokinetics of Belviq in adult Korean volunteers.
Detailed Description:
The volunteers are screened through medical history, physical exam, laboratory tests etc. within 4 weeks (-28d\~-2d) prior to the day scheduled for taking the investigational product (1d). The final subjects determined eligible for this clinical trial through screening tests are randomized to the dose groups with Belviq 10 mg and 20 mg. Twelve subjects are assigned to each group (9 subjects to study drug and 3 subjects to placebo), and the study drug or placebo are administered to the corresponding administration group. The subjects are discharged on the morning of 4d after completing the set study schedule at 72 hours after administration. The subjects then visit for the final tests on the last out-patient visiting day. Belviq is progressed sequentially from the low-dose group to the high-dose group.
The blood sampling time for the pharmacokinetic evaluation is as follows. Blood sampling for pharmacokinetic evaluation
: Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication.
The blood sampling time for the pharmacokinetic evaluation is as follows. Blood sampling for pharmacokinetic evaluation
: Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: