NCT01367080

A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg

Clinical Trials to Compare the Pharmacokinetics Profile of Etravil®(Amitriptyline Hydrochloride) Tablet 10mg and Etravil®(Amitriptyline Hydrochloride) Tablet 25mg After a Single Oral Administration in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Dong Wha Pharmaceutical Co. Ltd. · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride film-coated tablet 10mg \& 25mg

Detailed description

Randomized, Single dose, 2-way crossover, Open Study to compare the pharmacokinetics profile of Etravil®(Amitriptyline Hydrochloride) Tablet 10mg and Etravil®(Amitriptyline Hydrochloride) Tablet 25mg after a single oral administration in healthy male volunteers

Conditions

• Depression
• Depressive State
• Enuresis

Interventions

Type	Name	Description
DRUG	DWETR10	Amitriptyline hydrochloride 10mg(DWETR10) single dose
DRUG	DWETR25	Amitriptyline hydrochloride 25mg(DWETR25) single dose

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2011-06-06
• Last updated: 2014-08-22
• Results posted: 2014-08-22

Locations

1 site across 1 country: South Korea