NCT01016626

Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 (Mycophenolate Mofetil) Tablet

Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 Tablet, in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the CKD-4101 tablet and Mycophenolate mofetil capsule when administered alone to healthy volunteers.

Detailed description

Healthy volunteers are administrated single-dose over the period I and II (Crossover) of CKD-4101 1000mg and Mycophenolate mofetil capsule 1000mg. Every time before and after each medication, PK parameters and safety of CKD-4101 tablet and Mycophenolate mofetil capsule is performed using a blood sample and conducting some tests respectively.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CKD-4101 tablet	CKD-4101 tablet 1000 mg * 500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover)
DRUG	Mycophenolate Mofetil capsule	Mycophenolate Mofetil capsule 1000 mg * 250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover)

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-08-01
• Completion: 2009-10-01
• First posted: 2009-11-19
• Last updated: 2009-11-19

Locations

1 site across 1 country: South Korea