Trial Outcomes & Findings for Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate (NCT NCT00939562)
NCT ID: NCT00939562
Last Updated: 2009-12-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.
Results posted on
2009-12-23
Participant Flow
Participant milestones
| Measure |
Doxycycline Monohydrate, Then Doxycycline Carragenate
Single dose of one 100 mg doxycycline monohydrate tablet (Test) during first period and single dose of one 100 mg doxycycline carragenate tablet (Reference) during the second period.
|
Doxycycline Carragenate, Then Doxycycline Monohydrate
Single dose of one 100 mg doxycycline carragenate tablet (Reference) during first period and single dose of one 100 mg doxycycline monohydrate tablet (Test) during the second period.
|
|---|---|---|
|
Period 1
STARTED
|
12
|
12
|
|
Period 1
COMPLETED
|
12
|
12
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
12
|
12
|
|
Period 2
COMPLETED
|
12
|
12
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=24 Participants
Includes subjects who received a single dose of one 100 mg doxycycline monohydrate tablet (Test) and a single dose of one 100 mg doxycycline carragenate tablet (Reference).
|
|---|---|
|
Age, Customized
< 18 years
|
0 participants
n=5 Participants
|
|
Age, Customized
18 to 44 years
|
24 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
0 participants
n=5 Participants
|
|
Age, Customized
> = 65 years
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.Population: The pharmacokinetic (PK) concentration population was defined as all subjects randomized and treated who had at least 1 concentration in at least 1 treatment period.
Outcome measures
| Measure |
Doxycycline Monohydrate
n=24 Participants
Single dose of one 100 mg doxycycline monohydrate tablet (Test).
|
Doxycycline Carragenate
n=24 Participants
Single dose of one 100 mg doxycycline carragenate tablet (Reference).
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Doxycycline
|
2.526 ug/mL
Standard Deviation 0.5090
|
2.442 ug/mL
Standard Deviation 0.4585
|
PRIMARY outcome
Timeframe: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.Population: PK
AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.
Outcome measures
| Measure |
Doxycycline Monohydrate
n=24 Participants
Single dose of one 100 mg doxycycline monohydrate tablet (Test).
|
Doxycycline Carragenate
n=24 Participants
Single dose of one 100 mg doxycycline carragenate tablet (Reference).
|
|---|---|---|
|
Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline
|
56.297 ug*hr/mL
Standard Deviation 10.3348
|
54.026 ug*hr/mL
Standard Deviation 11.4855
|
Adverse Events
Doxycycline Monohydrate
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Doxycycline Carragenate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Doxycycline Monohydrate
n=24 participants at risk
Single dose of one 100 mg doxycycline monohydrate tablet (Test).
|
Doxycycline Carragenate
n=24 participants at risk
Single dose of one 100 mg doxycycline carragenate tablet (Reference).
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/24
|
4.2%
1/24
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/24
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.2%
1/24
|
0.00%
0/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER