Trial Outcomes & Findings for Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions (NCT NCT00829673)
NCT ID: NCT00829673
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Blood samples collected over a 16 hour period.
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Dexmethylphenidate HCl First
10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
|
Focalin® First
10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
12
|
12
|
|
First Intervention
COMPLETED
|
12
|
12
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
12
|
12
|
|
Washout of 7 Days
COMPLETED
|
11
|
12
|
|
Washout of 7 Days
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
11
|
12
|
|
Second Intervention
COMPLETED
|
11
|
12
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dexmethylphenidate HCl First
10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
|
Focalin® First
10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
|
|---|---|---|
|
Washout of 7 Days
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions
Baseline characteristics by cohort
| Measure |
Dexmethylphenidate HCl First
n=12 Participants
10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
|
Focalin® First
n=12 Participants
10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
|
Total
n=24 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 16 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Dexmethylphenidate HCl
n=23 Participants
10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
|
Focalin®
n=23 Participants
10 mg Focalin® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration)
|
15668.17 pg/mL
Standard Deviation 5081.48
|
14526.09 pg/mL
Standard Deviation 4639.79
|
PRIMARY outcome
Timeframe: Blood samples collected over a 16 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Dexmethylphenidate HCl
n=23 Participants
10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
|
Focalin®
n=23 Participants
10 mg Focalin® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
81531.55 pg*h/mL
Standard Deviation 40876.96
|
79972.63 pg*h/mL
Standard Deviation 35905.93
|
PRIMARY outcome
Timeframe: Blood samples collected over a 16 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Dexmethylphenidate HCl
n=23 Participants
10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
|
Focalin®
n=23 Participants
10 mg Focalin® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
86046.67 pg*h/mL
Standard Deviation 49869.68
|
84376.75 pg*h/mL
Standard Deviation 43435.19
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER