Trial Outcomes & Findings for Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions. (NCT NCT00840216)
NCT ID: NCT00840216
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 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 Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
|
Biaxin® (Reference) First
Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
|
|---|---|---|
|
First Intervention
STARTED
|
11
|
11
|
|
First Intervention
COMPLETED
|
11
|
11
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout: 7 Days
STARTED
|
11
|
11
|
|
Washout: 7 Days
COMPLETED
|
10
|
11
|
|
Washout: 7 Days
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
10
|
11
|
|
Second Intervention
COMPLETED
|
10
|
11
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Clarithromycin (Test) First
Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
|
Biaxin® (Reference) First
Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
|
|---|---|---|
|
Washout: 7 Days
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.
Baseline characteristics by cohort
| Measure |
Clarithromycin (Test) First
n=11 Participants
Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
|
Biaxin® (Reference) First
n=11 Participants
Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
|
Total
n=22 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 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
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Clarithromycin
n=21 Participants
Clarithromycin 500 mg ER Tablets (test) dosed in either period
|
Biaxin®
n=21 Participants
Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration
|
1515.00 ng/mL
Standard Deviation 533.782
|
1464.10 ng/mL
Standard Deviation 700.030
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Clarithromycin
n=21 Participants
Clarithromycin 500 mg ER Tablets (test) dosed in either period
|
Biaxin®
n=21 Participants
Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
14449.3 ng*h/mL
Standard Deviation 4684.11
|
15699.8 ng*h/mL
Standard Deviation 5991.11
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Clarithromycin
n=21 Participants
Clarithromycin 500 mg ER Tablets (test) dosed in either period
|
Biaxin®
n=21 Participants
Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration
|
14236.7 ng*h/mL
Standard Deviation 4681.28
|
15389.5 ng*h/mL
Standard Deviation 5923.27
|
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 Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER