Trial Outcomes & Findings for Venlafaxine 25 mg Tablets Under Fasting Conditions (NCT NCT00834964)

NCT ID: NCT00834964

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 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	15	15
First Intervention COMPLETED	15	15
First Intervention NOT COMPLETED	0	0
Washout: 7 Days STARTED	15	15
Washout: 7 Days COMPLETED	15	15
Washout: 7 Days NOT COMPLETED	0	0
Second Intervention STARTED	15	15
Second Intervention COMPLETED	15	15
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Venlafaxine 25 mg Tablets Under Fasting Conditions

Baseline characteristics by cohort

Measure	Venlafaxine (Test) First n=15 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=15 Participants Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period	Total n=30 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	15 Participants n=5 Participants	15 Participants n=7 Participants	30 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	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment Canada	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from first 24 completed subjects were included in the statistical analysis per protocol.

Bioequivalence based on Cmax

Outcome measures

Measure	Venlafaxine n=24 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=24 Participants Effexor® 25 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration - Venlafaxine in Plasma	38.11 ng/mL Standard Deviation 19.19	39.91 ng/mL Standard Deviation 20.93

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from first 24 completed subjects were included in the statistical analysis per protocol.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Venlafaxine n=24 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=24 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	327.78 ng*h/mL Standard Deviation 447.01	309.75 ng*h/mL Standard Deviation 367.58

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from first 24 completed subjects were included in the statistical analysis per protocol.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Venlafaxine n=24 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=24 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	273.66 ng*h/mL Standard Deviation 266.95	273.03 ng*h/mL Standard Deviation 260.66

SECONDARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from first 24 completed subjects were included in the statistical analysis per protocol.

Informational Purposes Only

Outcome measures

Measure	Venlafaxine n=24 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=24 Participants Effexor® 25 mg Tablet (reference) dosed in either period
Cmax - O-Desmethylvenlafaxine in Plasma	60.01 ng/mL Standard Deviation 22.83	62.07 ng/mL Standard Deviation 22.39

SECONDARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from first 24 completed subjects were included in the statistical analysis per protocol.

Informational Purposes Only

Outcome measures

Measure	Venlafaxine n=24 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=24 Participants Effexor® 25 mg Tablet (reference) dosed in either period
AUC0-inf - O-Desmethylvenlafaxine in Plasma	1181.30 ng*h/mL Standard Deviation 478.25	1123.62 ng*h/mL Standard Deviation 415.84

SECONDARY outcome

Timeframe: Blood samples collected over24 hour period

Population: Data from first 24 completed subjects were included in the statistical analysis per protocol.

Informational Purposes Only

Outcome measures

Measure	Venlafaxine n=24 Participants Venlafaxine 25 mg Tablet (test) dosed in either period	Effexor® n=24 Participants Effexor® 25 mg Tablet (reference) dosed in either period
AUC0-t - O-Desmethylvenlafaxine in Plasma	844.35 ng*h/mL Standard Deviation 316.73	838.37 ng*h/mL Standard Deviation 306.54

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