NCT01880502

Pharmacokinetic Study of Belviq in Adult Korean Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: IlDong Pharmaceutical Co Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Belviq 10mg	Belviq 10mg single dose administration
DRUG	Belviq 20mg	Belviq 20mg single dose administration
DRUG	Placebo	Placebo single dose administration

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-07-01
• Completion: 2013-10-01
• First posted: 2013-06-19
• Last updated: 2013-10-14

Locations

1 site across 1 country: South Korea