Trial Outcomes & Findings for Clarithromycin 500 mg Tablets Under Fasting Conditions (NCT NCT00835692)
NCT ID: NCT00835692
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Blood samples collected over 48 hour period
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Clarithromycin (Test) First
Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
|
Biaxin® (Reference) First
Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
28
|
28
|
|
First Intervention
COMPLETED
|
27
|
28
|
|
First Intervention
NOT COMPLETED
|
1
|
0
|
|
Washout
STARTED
|
27
|
28
|
|
Washout
COMPLETED
|
27
|
28
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
27
|
28
|
|
Second Intervention
COMPLETED
|
27
|
28
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Clarithromycin (Test) First
Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
|
Biaxin® (Reference) First
Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Clarithromycin 500 mg Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Clarithromycin (Test) First
n=28 Participants
Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
|
Biaxin® (Reference) First
n=28 Participants
Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
27 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
28 participants
n=107 Participants
|
56 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Clarithromycin
n=55 Participants
Clarithromycin 500 mg Tablet (test) dosed in either period
|
Biaxin®
n=55 Participants
Biaxin® 500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration
|
2170.964 ng/mL
Standard Deviation 690.215
|
2214.636 ng/mL
Standard Deviation 763.844
|
PRIMARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Clarithromycin
n=55 Participants
Clarithromycin 500 mg Tablet (test) dosed in either period
|
Biaxin®
n=55 Participants
Biaxin® 500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
17380.442 ng*h/mL
Standard Deviation 6167.362
|
18481.089 ng*h/mL
Standard Deviation 5728.638
|
PRIMARY outcome
Timeframe: Blood samples collected over 48 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Clarithromycin
n=55 Participants
Clarithromycin 500 mg Tablet (test) dosed in either period
|
Biaxin®
n=55 Participants
Biaxin® 500 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)
|
17265.639 ng*h/mL
Standard Deviation 6136.361
|
18362.380 ng*h/mL
Standard Deviation 5719.467
|
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