Investigating the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HGP0904; Drug: HGP1201; Drug: HGP0904 and HGP1201 co-administraion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02243319

HM-TARO-101

Details and patient eligibility

About

The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

Full description

Randomized, open-label, multiple dose , 3-treatment, 6-sequence, 3-period, crossover study, The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

Enrollment: 24 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteer, age 19~45 years
• The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
• Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

Exclusion criteria

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
• History of relevant drug allergies or clinically significant hypersensitivity reaction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Group 1

Experimental group

Description:

A → B → C A: HGP1201 for 9 days B: HGP0904 for 9 days C: HGP1201+ HGP0904 for 9 days

Treatment:

Drug: HGP0904 and HGP1201 co-administraion

Drug: HGP1201

Drug: HGP0904

Group 2

Experimental group

Description:

C → A → B

Treatment:

Drug: HGP0904 and HGP1201 co-administraion

Drug: HGP1201

Drug: HGP0904

Group 3

Experimental group

Description:

B → C → A

Treatment:

Drug: HGP0904 and HGP1201 co-administraion

Drug: HGP1201

Drug: HGP0904

Group 4

Experimental group

Description:

C → B → A

Treatment:

Drug: HGP0904 and HGP1201 co-administraion

Drug: HGP1201

Drug: HGP0904

Group 5

Experimental group

Description:

B → A → C

Treatment:

Drug: HGP0904 and HGP1201 co-administraion

Drug: HGP1201

Drug: HGP0904

Group 6

Experimental group

Description:

A → C → B

Treatment:

Drug: HGP0904 and HGP1201 co-administraion

Drug: HGP1201

Drug: HGP0904