CompletedNCT01367080DWETRUpdated Aug 22, 2014Results posted

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

A Phase 1 interventional study of DWETR10 and DWETR25 in Depression, Depressive State and Enuresis, sponsored by Dong Wha Pharmaceutical Co. Ltd.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-22.

Sponsored by Dong Wha Pharmaceutical Co. Ltd. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 19 Years to 50 Years
Sex: Male

Study summary

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

Read the 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 studied

Depression
Depressive State
Enuresis

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Keywords

depression

In context

Enuresis

845 studies on the registry are indexed under Enuresis; 81 are open to participants now.

This study's enrollment of 12 is below the median of 64 across 654 interventional studies indexed under Enuresis.

Browse Enuresis studies →

Lead sponsor

Dong Wha Pharmaceutical Co. Ltd. is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 50 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

a healthy adult male within the range of 19 to 50 years old at the time of screening
one with weight of more than 55kg, in the range of IBW 20%
- Ideal Body Weight(IBW)(kg)={height(cm)-100}*0.9
one who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol.

Exclusion criteria

Exclusion Criteria:

one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
one with glaucoma
one with disorders of micturition include benign prostatic hyperplasia
one with gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
one who is allergic or has clinically significant allergic history to the study drug, components or tricyclic antidepressants(TCA)
one who shows the following result in vital sign: hypotension(systolic pressure ≤ 100mmHg or diastolic pressure ≤ 65mmHg) or hypertension(systolic pressure ≥ 150mmHg or diastolic pressure ≥ 95mmHg)
one who has drug abuse history
one who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
one who has participated in other clinical study within 2 months before study drug administration
one who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
one who drank Over 21 units/week of alcohol(1 unit = 10g of pure alcohol) or subjects who would not be able to stop drinking alcohol during the hospitalization
one who are heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization
one who had a beverage containing caffeine, drank alcohol, or smoked within 48hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
one with clinically significant observations considered as unsuitable based on medical judgment by investigators

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 12 participants (actual)

Study arms

Experimental
A Group
1. 1st administration - DWETR10 2. 2nd administration - DWETR25
Drug: DWETR10 · Drug: DWETR25
Experimental
B Group
1. 1st administration - DWETR25 2. 2nd administration - DWETR10
Drug: DWETR10 · Drug: DWETR25

Interventions

DrugDWETR10
Amitriptyline hydrochloride 10mg(DWETR10) single dose
Also known as: Etravil 10mg
DrugDWETR25
Amitriptyline hydrochloride 25mg(DWETR25) single dose
Also known as: Etravil 25mg

What researchers measure

Primary outcomes

AUClast and AUCinf
Area Under the Plasma concentration-time curve from time Zero to Infinity(AUCinf) and Area Under the Plasma concentration-time curve from time Zero to last time(AUClast) of Amitryptiline in plasma
Time frame: Up to 72 hours

Secondary outcomes

Cmax
Maximum Concentration(Cmax) of amitryptyline in plasma
Time frame: Up to 72 hours
Tmax
Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma
Time frame: Up to 72 hours
t1/2
Terminal half-time(t1/2) of Amitryptyline in Plasma
Time frame: Up to 72 hours

Results

Posted Aug 22, 2014

Limitations and caveats

When collecting blood samples, few subjects were drawn blood later than that stated in protocol for about 1 \~ 2 minutes where results may not be effected. One of the subjects came in late for Post-study visit for about 4\~6 days.

Participant flow

Participants recruited from a specialty clinic at a hospital, Korea between July 2011 and August 2011

1st Administration

Participant flow — 1st Administration
Milestone	A Group	B Group
Started	6	6
Completed	6	6
Not completed	0	0

2nd Administration

Participant flow — 2nd Administration
Milestone	A Group	B Group
Started	6	6
Completed	6	6
Not completed	0	0

Outcome measures

PrimaryAUClast and AUCinf

Area Under the Plasma concentration-time curve from time Zero to Infinity(AUCinf) and Area Under the Plasma concentration-time curve from time Zero to last time(AUClast) of Amitryptiline in plasma

Time frame:: Up to 72 hours
Reported as:: Mean · ng*hr/mL

AUClast and AUCinf
ng*hr/mL	Etravil 10mg Group	Etravil 25mg Group
AUClast	91.35 ± 25.88	260.68 ± 111.57
AUCinf	109.74 ± 37.80	296.87 ± 124.99

SecondaryCmax

Maximum Concentration(Cmax) of amitryptyline in plasma

Time frame:: Up to 72 hours
Reported as:: Mean · ng/mL

Cmax
ng/mL	Etravil 10mg Group	Etravil 25mg Group
Cmax	5.96 ± 1.40	17.69 ± 5.27

SecondaryTmax

Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma

Time frame:: Up to 72 hours
Reported as:: Mean · hour

Tmax
hour	Etravil 10mg Group	Etravil 25mg Group
Tmax	3.50 ± 0.90	3.13 ± 0.61

Secondaryt1/2

Terminal half-time(t1/2) of Amitryptyline in Plasma

Time frame:: Up to 72 hours
Reported as:: Mean · hour

t1/2
hour	Etravil 10mg Group	Etravil 25mg Group
t1/2	26.47 ± 5.64	24.79 ± 3.22

Adverse events

Collected over About a month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Etravil 10mg Group	—	0/12 (0%)	2/12 (16.7%)
Etravil 25mg Group	—	0/12 (0%)	2/12 (16.7%)

Most frequent other events

Most frequent other events
Event	Etravil 10mg Group	Etravil 25mg Group
DizzinessNervous system disorders	2/12	1/12
AstheniaGeneral disorders	1/12	1/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	A Group	B Group	Total
<=18 years	0	0	0
Between 18 and 65 years	6	6	12
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	A Group	B Group	Total
Mean	22.2 ± 2.1	21.2 ± 2.1	21.7 ± 1.9

Sex: Female, Male
Sex: Female, Male(Participants)	A Group	B Group	Total
Female	0	0	0
Male	6	6	12

Region of Enrollment
Region of Enrollment(participants)	A Group	B Group	Total
Korea, Republic of	6	6	12

Study locations

1 site

Chonbuk National University Hospital.
Jeonju-si, Jeollabuk-do 561-712, Korea, Republic of

References and documents

Publications

Nam Y, Lim CH, Lee HS, Chung SJ, Chung YH, Shin YK, Kim MG, Sohn UD, Kim HC, Jeong JH. Single-dose, randomized, open-label, 2-way crossover study of the pharmacokinetics of amitriptyline hydrochloride 10- and 25-mg tablet in healthy male Korean volunteers. Clin Ther. 2015 Feb 1;37(2):302-10. doi: 10.1016/j.clinthera.2014.09.010. Epub 2014 Oct 11. PubMed 25308868 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01367080
Lead sponsor: Dong Wha Pharmaceutical Co. Ltd.
Collaborators: Chonbuk National University Hospital
Responsible party: Sponsor
First posted: Jun 6, 2011
Start date: Jul 2011
Primary completion: Aug 2011
Completion: Sep 2011
Results posted: Aug 22, 2014
Last update: Aug 22, 2014

Study contacts

Min-Gul Kim, MD, PhD

principal investigator · Chonbuk National University Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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