Trial Outcomes & Findings for A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg (NCT NCT01367080)
NCT ID: NCT01367080
Last Updated: 2014-08-22
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Up to 72 hours
Results posted on
2014-08-22
Participant Flow
Participants recruited from a specialty clinic at a hospital, Korea between July 2011 and August 2011
15 participants recruited ; 12 screened, 3 excluded (2 did not meet inclusion criteria and 1 refused participation)
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
1st Administration
STARTED
|
6
|
6
|
|
1st Administration
COMPLETED
|
6
|
6
|
|
1st Administration
NOT COMPLETED
|
0
|
0
|
|
2nd Administration
STARTED
|
6
|
6
|
|
2nd Administration
COMPLETED
|
6
|
6
|
|
2nd Administration
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg
Baseline characteristics by cohort
| Measure |
A Group
n=6 Participants
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)
|
B Group
n=6 Participants
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)
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
22.2 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
21.2 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
21.7 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 72 hoursArea 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
Outcome measures
| Measure |
Etravil 10mg Group
n=12 Participants
Amitryptiline Hydrochloride 10mg administration Group
|
Etravil 25mg Group
n=12 Participants
Amitryptiline hydrochloride 25mg administration Group
|
|---|---|---|
|
AUClast and AUCinf
AUClast
|
91.35 ng*hr/mL
Standard Deviation 25.88
|
260.68 ng*hr/mL
Standard Deviation 111.57
|
|
AUClast and AUCinf
AUCinf
|
109.74 ng*hr/mL
Standard Deviation 37.80
|
296.87 ng*hr/mL
Standard Deviation 124.99
|
SECONDARY outcome
Timeframe: Up to 72 hoursMaximum Concentration(Cmax) of amitryptyline in plasma
Outcome measures
| Measure |
Etravil 10mg Group
n=12 Participants
Amitryptiline Hydrochloride 10mg administration Group
|
Etravil 25mg Group
n=12 Participants
Amitryptiline hydrochloride 25mg administration Group
|
|---|---|---|
|
Cmax
|
5.96 ng/mL
Standard Deviation 1.40
|
17.69 ng/mL
Standard Deviation 5.27
|
SECONDARY outcome
Timeframe: Up to 72 hoursTime for Maximum Concentration(Tmax) of Amitryptyline in Plasma
Outcome measures
| Measure |
Etravil 10mg Group
n=12 Participants
Amitryptiline Hydrochloride 10mg administration Group
|
Etravil 25mg Group
n=12 Participants
Amitryptiline hydrochloride 25mg administration Group
|
|---|---|---|
|
Tmax
|
3.50 hour
Standard Deviation 0.90
|
3.13 hour
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Up to 72 hoursTerminal half-time(t1/2) of Amitryptyline in Plasma
Outcome measures
| Measure |
Etravil 10mg Group
n=12 Participants
Amitryptiline Hydrochloride 10mg administration Group
|
Etravil 25mg Group
n=12 Participants
Amitryptiline hydrochloride 25mg administration Group
|
|---|---|---|
|
t1/2
|
26.47 hour
Standard Deviation 5.64
|
24.79 hour
Standard Deviation 3.22
|
Adverse Events
Etravil 10mg Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Etravil 25mg Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Etravil 10mg Group
n=12 participants at risk
Amitryptyline hydrochloride 10mg administration Group
|
Etravil 25mg Group
n=12 participants at risk
Amitryptyline hydrochloride 25mg administration Group
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • About a month
|
8.3%
1/12 • Number of events 1 • About a month
|
|
General disorders
Asthenia
|
8.3%
1/12 • Number of events 1 • About a month
|
8.3%
1/12 • Number of events 1 • About a month
|
Additional Information
Cheol-Hee Lim. Clinical Research Manager (CRM)
Dong Wha Pharm. Co. Ltd.
Phone: +82-2-2021-9300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place