Trial Outcomes & Findings for Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fasting Conditions (NCT NCT00829764)
NCT ID: NCT00829764
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 a 72 hour period.
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Doxycycline Monohydrate First
25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
|
Vibramycin® Monohydrate First
25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
15
|
15
|
|
First Intervention
COMPLETED
|
13
|
14
|
|
First Intervention
NOT COMPLETED
|
2
|
1
|
|
Washout of 14 Days
STARTED
|
13
|
14
|
|
Washout of 14 Days
COMPLETED
|
13
|
14
|
|
Washout of 14 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
13
|
14
|
|
Second Intervention
COMPLETED
|
13
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Doxycycline Monohydrate First
25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
|
Vibramycin® Monohydrate First
25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
|
|---|---|---|
|
First Intervention
Adverse Event
|
1
|
0
|
|
First Intervention
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Doxycycline Monohydrate First
n=15 Participants
25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
|
Vibramycin® Monohydrate First
n=15 Participants
25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the 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
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 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 |
Doxycycline Monohydrate
n=27 Participants
25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
|
Vibramycin® Monohydrate
n=27 Participants
25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
|
|---|---|---|
|
Cmax = Maximum Observed Concentration.
|
363 ng/mL
Standard Deviation 105
|
383 ng/mL
Standard Deviation 96.5
|
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-t.
Outcome measures
| Measure |
Doxycycline Monohydrate
n=27 Participants
25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
|
Vibramycin® Monohydrate
n=27 Participants
25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
|
|---|---|---|
|
AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.
|
5769 ng*h/mL
Standard Deviation 1327
|
5870 ng*h/mL
Standard Deviation 1225
|
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-inf.
Outcome measures
| Measure |
Doxycycline Monohydrate
n=27 Participants
25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
|
Vibramycin® Monohydrate
n=27 Participants
25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
|
6195 ng*h/mL
Standard Deviation 1437
|
6250 ng*h/mL
Standard Deviation 1288
|
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