Trial Outcomes & Findings for 15 mg Mirtazapine Orally Disintegrating Tablets, Fasting (NCT NCT00835575)
NCT ID: NCT00835575
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Blood samples collected over a 120 hour period.
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Test (Mirtazapine) First
15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
|
Reference (Remeron®) First
15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
16
|
16
|
|
First Intervention
COMPLETED
|
16
|
16
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 14 Days
STARTED
|
16
|
16
|
|
Washout of 14 Days
COMPLETED
|
15
|
16
|
|
Washout of 14 Days
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
15
|
16
|
|
Second Intervention
COMPLETED
|
15
|
16
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test (Mirtazapine) First
15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
|
Reference (Remeron®) First
15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
|
|---|---|---|
|
Washout of 14 Days
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
15 mg Mirtazapine Orally Disintegrating Tablets, Fasting
Baseline characteristics by cohort
| Measure |
Test (Mirtazapine) First
n=16 Participants
15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
|
Reference (Remeron®) First
n=16 Participants
15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
16 participants
n=99 Participants
|
15 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
16 participants
n=107 Participants
|
32 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 120 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Mirtazapine)
n=31 Participants
15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
|
Reference (Remeron®)
n=31 Participants
15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
|
32975.95 pg/mL
Standard Deviation 11873.83
|
33122.52 pg/mL
Standard Deviation 11246.45
|
PRIMARY outcome
Timeframe: Blood samples collected over a 120 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Test (Mirtazapine)
n=31 Participants
15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
|
Reference (Remeron®)
n=31 Participants
15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
303749.52 pg*h/mL
Standard Deviation 104877.35
|
294920.42 pg*h/mL
Standard Deviation 105344.06
|
PRIMARY outcome
Timeframe: Blood samples collected over a 120 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Test (Mirtazapine)
n=31 Participants
15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
|
Reference (Remeron®)
n=31 Participants
15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
327022.65 pg*h/mL
Standard Deviation 109980.75
|
316863.06 pg*h/mL
Standard Deviation 111509.8
|
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