NCT01901757

Single-dose, 2-way Crossover Open Study to Evaluate the Food Effect on the PK of HCP1201 in Healthy Volunteers

An Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of HCP1201 Tablet in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in fed versus fasted condition

Detailed description

An open-label, randomized, single-dose crossover study to evaluate the effect of food on the pharmacokinetics of HCP1201 tablet in healthy volunteers

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	HCP1201, Fasted followed by fed	There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fasted condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fed condition.
DRUG	HCP1201, Fed followed by fasted	There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fed condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fasted condition.

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-07-17
• Last updated: 2013-08-13

Locations

1 site across 1 country: South Korea