Bacterial Infection
Conditions
Keywords
Bioequivalence
Brief summary
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
Interventions
DRUGdoxycycline monohydrate tablet
Tablet, 100 mg, Single dose
DRUGdoxycycline carragenate tablet
Tablet, 100 mg, Single dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects between the ages of 18 and 55 years. * Body Mass Index (BMI) of 18 to 30 kg/m2.
Exclusion criteria
* Evidence or history of clinically significant abnormality. * Any condition possibly affecting drug absorption. * A positive urine drug screen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Doxycycline | 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. | — |
| Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline | 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. | AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population 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). | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Customized 18 to 44 years | 24 participants |
| Age, Customized < 18 years | 0 participants |
| Age, Customized 45 to 64 years | 0 participants |
| Age, Customized > = 65 years | 0 participants |
| Race/Ethnicity, Customized Asian | 24 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 24 | 2 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline
AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doxycycline Monohydrate | Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline | 56.297 ug*hr/mL | Standard Deviation 10.3348 |
| Doxycycline Carragenate | Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline | 54.026 ug*hr/mL | Standard Deviation 11.4855 |
Comparison: Natural log transformed AUCinf was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).90% CI: [98.95, 110.73]
Primary
Maximum Plasma Concentration (Cmax) of Doxycycline
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doxycycline Monohydrate | Maximum Plasma Concentration (Cmax) of Doxycycline | 2.526 ug/mL | Standard Deviation 0.509 |
| Doxycycline Carragenate | Maximum Plasma Concentration (Cmax) of Doxycycline | 2.442 ug/mL | Standard Deviation 0.4585 |
Comparison: Natural log transformed Cmax was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).90% CI: [94.74, 111.86]