15 mg Mirtazapine Orally Disintegrating Tablets, Fasting

This study has been completed.

Sponsor:

Information provided by:

Teva Pharmaceuticals USA

ClinicalTrials.gov Identifier:

NCT00835575

First received: January 30, 2009

Last updated: September 1, 2009

Last verified: September 2009

History of Changes

Results First Received: July 2, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Healthy
Interventions:	Drug: Mirtazapine 15 mg (Orally Disintegrating) Tablets Drug: REMERON SolTab® 15 mg Orally Disintegrating Tablets

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.

Participant Flow for 3 periods

Period 1: First Intervention

	Test (Mirtazapine) First	Reference (Remeron®) First
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Period 2: Washout of 14 Days

	Test (Mirtazapine) First	Reference (Remeron®) First
STARTED	16	16
COMPLETED	15	16
NOT COMPLETED	1	0
Withdrawal by Subject	1	0

Period 3: Second Intervention

	Test (Mirtazapine) First	Reference (Remeron®) First
STARTED	15	16
COMPLETED	15	16
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Test (Mirtazapine) First	Reference (Remeron®) First	Total
Number of Participants [units: participants]	16	16	32
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	16	16	32
>=65 years	0	0	0
Gender [units: participants]
Female	4	4	8
Male	12	12	24
Race/Ethnicity, Customized [units: participants]
Black	0	1	1
White	16	15	31
Region of Enrollment [units: participants]
United States	16	16	32

Outcome Measures

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1. Primary:

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 120 hour period. ]

Measure Type	Primary
Measure Title	Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Measure Description	Bioequivalence based on Cmax.
Time Frame	Blood samples collected over a 120 hour period.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants that completed the study had their samples analyzed.

Reporting Groups

	Description
Test (Mirtazapine)	15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
Reference (Remeron®)	15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.

Measured Values

	Test (Mirtazapine)	Reference (Remeron®)
Number of Participants Analyzed [units: participants]	31	31
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [units: pg/mL] Mean ± Standard Deviation	32975.95 ± 11873.83	33122.52 ± 11246.45

Statistical Analysis 1 for Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Ratio of the T/R geometric mean x 100 ^[3]	99.52
90% Confidence Interval	( 92.84 to 106.69 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
[3]	Other relevant estimation information:
	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.

2. Primary:

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 120 hour period. ]

Measure Type	Primary
Measure Title	AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Measure Description	Bioequivalence based on AUC0-t.
Time Frame	Blood samples collected over a 120 hour period.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants that completed the study had their samples analyzed.

Reporting Groups

	Description
Test (Mirtazapine)	15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
Reference (Remeron®)	15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.

Measured Values

	Test (Mirtazapine)	Reference (Remeron®)
Number of Participants Analyzed [units: participants]	31	31
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [units: pg*h/mL] Mean ± Standard Deviation	303749.52 ± 104877.35	294920.42 ± 105344.06

Statistical Analysis 1 for AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Ratio of the T/R geometric mean x 100 ^[3]	103.59
90% Confidence Interval	( 99.13 to 108.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
[3]	Other relevant estimation information:
	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.

3. Primary:

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 120 hour period. ]

Measure Type	Primary
Measure Title	AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Measure Description	Bioequivalence based on AUC0-inf.
Time Frame	Blood samples collected over a 120 hour period.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants that completed the study had their samples analyzed.

Reporting Groups

	Description
Test (Mirtazapine)	15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
Reference (Remeron®)	15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.

Measured Values

	Test (Mirtazapine)	Reference (Remeron®)
Number of Participants Analyzed [units: participants]	31	31
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [units: pg*h/mL] Mean ± Standard Deviation	327022.65 ± 109980.75	316863.06 ± 111509.8

Statistical Analysis 1 for AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Ratio of the T/R geometric mean x 100 ^[3]	103.87
90% Confidence Interval	( 99.47 to 108.46 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
[3]	Other relevant estimation information:
	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Principal Investigator is not permitted to discuss or publish trial results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Manager, Biopharmaceutics
Organization: TEVA Pharmaceuticals, USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com

No publications provided

ClinicalTrials.gov Identifier:	NCT00835575 History of Changes
Other Study ID Numbers:	R03-338
Study First Received:	January 30, 2009
Results First Received:	July 2, 2009
Last Updated:	September 1, 2009
Health Authority:	United States: Institutional Review Board

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