DepressionPhase 1DWETRNCT01367080

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

A Phase 1 study testing DWETR10 and DWETR25 in people with Depression and Depressive State, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride film-coated tablet 10mg \& 25mg Read more about this study

Who is it for?: Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Depression, Depressive State, Enuresis
What is being tested?: DWETR10 and DWETR25
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteSouth Korea
Study dates: Jul 2011to Sep 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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)

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chonbuk National University Hospital.
Jeonju, Jeollabuk-do, 561-712

Other trials in South Korea

About this study

Official title: 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

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: Depression, Depressive State, Enuresis
Being tested: DWETR10, DWETR25
Keywords: depression
Medical subject headings: Depression, Enuresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DWETR10Drug
Also called Etravil 10mg
Amitriptyline hydrochloride 10mg(DWETR10) single dose
DWETR25Drug
Also called Etravil 25mg
Amitriptyline hydrochloride 25mg(DWETR25) single dose

Study groups in NCT01367080
Study group	Role	What they receive
A Group	Experimental	1. 1st administration - DWETR10 2. 2nd administration - DWETR25 Receives: Drug: DWETR10; Drug: DWETR25
B Group	Experimental	1. 1st administration - DWETR25 2. 2nd administration - DWETR10 Receives: Drug: DWETR10; Drug: DWETR25

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Up to 72 hours

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Sep 2011

First posted6 Jun 2011 (estimated)
Study startJul 2011
Primary completionAug 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01367080
Sponsor's protocol ID: DWETR-I-1
Acronym: DWETR
Status last verified: Aug 2014
First submitted: 2 Jun 2011
Last updated: 22 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01367080
Acronym / sponsor ID: DWETR / DWETR-I-1
Conditions: Depression, Depressive State, Enuresis
Keywords: depression
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Dong Wha Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
Collaborators: Chonbuk National University Hospital
Study start: Jul 2011
Primary completion: Aug 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 6 Jun 2011 (estimated)
Results: Posted 22 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A Group	Experimental	Drug: DWETR10, Drug: DWETR251. 1st administration - DWETR10 2. 2nd administration - DWETR25
B Group	Experimental	Drug: DWETR10, Drug: DWETR251. 1st administration - DWETR25 2. 2nd administration - DWETR10

Who may qualify

Ages: 19 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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%
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.

Key exclusion criteria (14 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DWETR10Also: Etravil 10mgAmitriptyline hydrochloride 10mg(DWETR10) single dose	Drug	A Group, B Group
DWETR25Also: Etravil 25mgAmitriptyline hydrochloride 25mg(DWETR25) single dose	Drug	A Group, B Group

Primary outcome

AUClast and AUCinf
Time frame: Up to 72 hours
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

3 secondary outcomes

Cmax
Time frame: Up to 72 hours
Tmax
Time frame: Up to 72 hours
t1/2
Time frame: Up to 72 hours

Results and safety

Results posted to the registry on 22 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A Group	6	6
B Group	6	6

Primary outcome: AUClast and AUCinf

Time frame: Up to 72 hours. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Etravil 10mg Group n = 12	Etravil 25mg Group n = 12
AUClast	91.35 (25.88)	260.68 (111.57)
AUCinf	109.74 (37.80)	296.87 (124.99)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: About a month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etravil 10mg Group	0 of 12 (0%)	2 of 12 (16.7%)	Not reported
Etravil 25mg Group	0 of 12 (0%)	2 of 12 (16.7%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25308868Nam 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Min-Gul Kim, MD, PhD principal investigator

Chonbuk National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DWETR10 and DWETR25 in people with Depression and Depressive State, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUClast and AUCinf (time frame: Up to 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01367080, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.