Trial Outcomes & Findings for Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions (NCT NCT00840411)

NCT ID: NCT00840411

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 66 participants
• Primary outcome timeframe: Blood samples collected over 36 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Clarithromycin (Test) First Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.	Biaxin® XL (Reference) First Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
First Intervention STARTED	33	33
First Intervention COMPLETED	32	33
First Intervention NOT COMPLETED	1	0
Washout STARTED	32	33
Washout COMPLETED	31	33
Washout NOT COMPLETED	1	0
Second Intervention STARTED	31	33
Second Intervention COMPLETED	31	33
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Clarithromycin (Test) First Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.	Biaxin® XL (Reference) First Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
First Intervention Adverse Event	1	0
Washout Withdrawal by Subject	1	0

Baseline Characteristics

Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions

Baseline characteristics by cohort

Measure	Clarithromycin (Test) First n=33 Participants Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.	Biaxin® XL (Reference) First n=33 Participants Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period	Total n=66 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	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	24 Participants n=5 Participants	29 Participants n=7 Participants	53 Participants n=5 Participants
Race/Ethnicity, Customized Black	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

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

Bioequivalence based on Cmax

Outcome measures

Measure	Clarithromycin n=62 Participants Clarithromycin 500 mg ER Tablet (test) dosed in either period	Biaxin® XL n=62 Participants Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
Cmax - Maximum Observed Concentration	640.08 ng/mL Standard Deviation 214.223	640.11 ng/mL Standard Deviation 231.752

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: AUCinf could not be estimated for some subjects.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Clarithromycin n=62 Participants Clarithromycin 500 mg ER Tablet (test) dosed in either period	Biaxin® XL n=58 Participants Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	10255.3 ng*h/mL Standard Deviation 4102.34	11767.7 ng*h/mL Standard Deviation 5131.84

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

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

Bioequivalence based on AUC0-t

Outcome measures

Measure	Clarithromycin n=62 Participants Clarithromycin 500 mg ER Tablet (test) dosed in either period	Biaxin® XL n=62 Participants Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration	9735.5 ng*h/mL Standard Deviation 3813.66	11136.6 ng*h/mL Standard Deviation 4412.82

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