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The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| doxycycline monohydrate tablet | Experimental |
| |
| doxycycline carragenate tablet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxycycline monohydrate tablet | Drug | Tablet, 100 mg, Single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Ahmedabad | Gujarat | 380 015 | India |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of Doxycycline | 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. | Posted | Mean | Standard Deviation | ug/mL | 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. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxycycline Monohydrate | Single dose of one 100 mg doxycycline monohydrate tablet (Test). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| doxycycline carragenate tablet |
| Drug |
Tablet, 100 mg, Single dose |
|
| NOT COMPLETED |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | PK | Posted | Mean | Standard Deviation | ug*hr/mL | 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. |
|
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| EG001 | Doxycycline Carragenate | Single dose of one 100 mg doxycycline carragenate tablet (Reference). | 0 | 24 | 2 | 24 |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
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.
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |