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| ID | Type | Description | Link |
|---|---|---|---|
| A3Q-ME-AFBS | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V. | OTHER |
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The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods. Participants will receive one preparation of cephalexin in each period. At least 7 hours will pass between the study periods. The study is expected to last about 2 days for each participant, not including screening or follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cephalexin (Reference) | Experimental | Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods. |
|
| Cephalexin (Test) | Active Comparator | Cephalexin manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cephalexin | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Cephalexin Following a Single Dose | Predose, 0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.500, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period | |
| Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin Following a Single Dose | Predose,0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mexico City | 14610 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cephalexin Dosing Sequence AB | Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion). |
| FG001 | Cephalexin Dosing Sequence BA | Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (19 Days) |
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| Washout Period (7 Days) |
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| Period 2 (19 Days) |
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All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cephalexin Dosing Sequence AB | Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion). |
| BG001 | Cephalexin Dosing Sequence BA |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Cephalexin Following a Single Dose | All randomized participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*microgram per milliliter (h*μg/mL) | Predose, 0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.500, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period |
|
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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 | Cephalexin (Reference) | Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D002506 | Cephalexin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Mexico |
| NOT COMPLETED |
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| NOT COMPLETED |
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Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin Following a Single Dose | All randomized participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter (μg/mL) | Predose,0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period |
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Cephalexin (Test) | Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods. | 0 | 14 | 1 | 14 |
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |