Depression, Depressive State, Enuresis
Conditions
Keywords
depression
Brief 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
Interventions
DRUGDWETR10
Amitriptyline hydrochloride 10mg(DWETR10) single dose
DRUGDWETR25
Amitriptyline hydrochloride 25mg(DWETR25) single dose
Sponsors
Chonbuk National University Hospital
Dong Wha Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
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
* 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUClast and AUCinf | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Up to 72 hours | Maximum Concentration(Cmax) of amitryptyline in plasma |
| Tmax | Up to 72 hours | Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma |
| t1/2 | Up to 72 hours | Terminal half-time(t1/2) of Amitryptyline in Plasma |
Countries
South Korea
Participant flow
Recruitment details
Participants recruited from a specialty clinic at a hospital, Korea between July 2011 and August 2011
Pre-assignment details
15 participants recruited ; 12 screened, 3 excluded (2 did not meet inclusion criteria and 1 refused participation)
Participants by arm
| Arm | Count |
|---|---|
| A Group Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day) | 6 |
| B Group Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day) | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | B Group | A Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Continuous | 21.2 years STANDARD_DEVIATION 2.1 | 22.2 years STANDARD_DEVIATION 2.1 | 21.7 years STANDARD_DEVIATION 1.9 |
| Region of Enrollment Korea, Republic of | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 12 | 2 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etravil 10mg Group | AUClast and AUCinf | AUClast | 91.35 ng*hr/mL | Standard Deviation 25.88 |
| Etravil 10mg Group | AUClast and AUCinf | AUCinf | 109.74 ng*hr/mL | Standard Deviation 37.8 |
| Etravil 25mg Group | AUClast and AUCinf | AUClast | 260.68 ng*hr/mL | Standard Deviation 111.57 |
| Etravil 25mg Group | AUClast and AUCinf | AUCinf | 296.87 ng*hr/mL | Standard Deviation 124.99 |
Secondary
Cmax
Maximum Concentration(Cmax) of amitryptyline in plasma
Time frame: Up to 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etravil 10mg Group | Cmax | 5.96 ng/mL | Standard Deviation 1.4 |
| Etravil 25mg Group | Cmax | 17.69 ng/mL | Standard Deviation 5.27 |
Secondary
t1/2
Terminal half-time(t1/2) of Amitryptyline in Plasma
Time frame: Up to 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etravil 10mg Group | t1/2 | 26.47 hour | Standard Deviation 5.64 |
| Etravil 25mg Group | t1/2 | 24.79 hour | Standard Deviation 3.22 |
Secondary
Tmax
Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma
Time frame: Up to 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etravil 10mg Group | Tmax | 3.50 hour | Standard Deviation 0.9 |
| Etravil 25mg Group | Tmax | 3.13 hour | Standard Deviation 0.61 |