Trial Outcomes & Findings for Venlafaxine 25 mg Tablets Under Non-Fasting Conditions (NCT NCT00834249)

NCT ID: NCT00834249

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 18 participants
• Primary outcome timeframe: Blood samples collected over 24 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Venlafaxine (Test) First Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period	Effexor® (Reference) First Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
First Intervention STARTED	9	9
First Intervention COMPLETED	9	9
First Intervention NOT COMPLETED	0	0
Washout: 7 Days STARTED	9	9
Washout: 7 Days COMPLETED	8	8
Washout: 7 Days NOT COMPLETED	1	1
Second Intervention STARTED	8	8
Second Intervention COMPLETED	7	8
Second Intervention NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Venlafaxine (Test) First Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period	Effexor® (Reference) First Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
Washout: 7 Days Withdrawal by Subject	1	1
Second Intervention Adverse Event	1	0

Baseline Characteristics

Venlafaxine 25 mg Tablets Under Non-Fasting Conditions

Baseline characteristics by cohort

Measure	Venlafaxine (Test) First n=9 Participants Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period	Effexor® (Reference) First n=9 Participants Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period	Total n=18 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	9 Participants n=5 Participants	9 Participants n=7 Participants	18 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	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Venlafaxine n=15 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=15 Participants Effexor® 25 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration - Venlafaxine in Plasma	47.13 ng/mL Standard Deviation 18.19	46.45 ng/mL Standard Deviation 20.28

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Venlafaxine n=15 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=15 Participants Effexor® 25 mg Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma	427.09 ng*h/mL Standard Deviation 357.42	422.70 ng*h/mL Standard Deviation 349.50

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Venlafaxine n=15 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=15 Participants Effexor® 25 mg Tablet (reference) dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma	366.94 ng*h/mL Standard Deviation 255.01	366.50 ng*h/mL Standard Deviation 261.20

SECONDARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Informational Purposes Only

Outcome measures

Measure	Venlafaxine n=15 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=15 Participants Effexor® 25 mg Tablet (reference) dosed in either period
Cmax - O-Desmethylvenlafaxine in Plasma	75.15 ng/mL Standard Deviation 32.88	69.17 ng/mL Standard Deviation 31.46

SECONDARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Informational Purposes Only

Outcome measures

Measure	Venlafaxine n=15 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=15 Participants Effexor® 25 mg Tablet (reference) dosed in either period
AUC0-inf - O-desmethylvenlafazine in Plasma	1390.43 ng*h/mL Standard Deviation 555.40	1315.02 ng*h/mL Standard Deviation 552.49

SECONDARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Informational Purposes Only

Outcome measures

Measure	Venlafaxine n=15 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=15 Participants Effexor® 25 mg Tablet (reference) dosed in either period
AUC0-t - O-desmethylvenlafaxine in Plasma	1016.24 ng*h/mL Standard Deviation 425.24	960.47 ng*h/mL Standard Deviation 407.72

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER