Trial Outcomes & Findings for Ribavirin 200 mg Tablets Under Fasting Conditions (NCT NCT00835146)
NCT ID: NCT00835146
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Blood samples collected over a 72 hour period.
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Test (Ribavirin) First
200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
|
Reference (Copegus®) First
200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
14
|
14
|
|
First Intervention
COMPLETED
|
14
|
14
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 5 Weeks
STARTED
|
14
|
14
|
|
Washout of 5 Weeks
COMPLETED
|
14
|
14
|
|
Washout of 5 Weeks
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
14
|
14
|
|
Second Intervention
COMPLETED
|
14
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ribavirin 200 mg Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Test (Ribavirin) First
n=14 Participants
200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
|
Reference (Copegus®) First
n=14 Participants
200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
|
Total
n=28 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
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 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
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Ribavirin)
n=28 Participants
200 mg Ribavirin Tablets test product dosed in either period.
|
Reference (Copegus®)
n=28 Participants
200 mg Copegus® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
|
518.357 ng/mL
Standard Deviation 217.183
|
526.357 ng/mL
Standard Deviation 215.994
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-72.
Outcome measures
| Measure |
Test (Ribavirin)
n=28 Participants
200 mg Ribavirin Tablets test product dosed in either period.
|
Reference (Copegus®)
n=28 Participants
200 mg Copegus® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)
|
5594.145 ng*h/mL
Standard Deviation 1358.537
|
5672.088 ng*h/mL
Standard Deviation 1546.054
|
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 The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER