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| Name | Class |
|---|---|
| CECYC (Center of Scientific and Clinical Studies, CRO) | UNKNOWN |
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This study compared the bioavailability of two formulations 100 mg (one capsule or other respectively) of each one of the products, of Minocycline, under fasting conditions, in healthy Mexican volunteers of both sexes. The single dose study under fasting (10 hours prior to study) conditions, cross, with two treatments, two periods, two sequences (2x2) randomized sequence, balanced, and with a washout period of at least 7 days between each dose, in 24 healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Minocycline 100 mg capsules Darier SA Dermatological Laboratories de CV (Micromycin ®). |
|
| Reference | Experimental | Minocycline 100 mg capsules (Micocin ®) Marketed and distributed by Triax Pharmaceuticals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline | Drug | minocycline hydrochloride capsules in microgranules equivalent to 100 mg of minocycline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability as assessed by composite of PK parameters. | The following pharmacokinetic (PK) parameters will assessed maximum observed concentration (Cmax), Area under the concentration time curve from time zero (pre-dose) to last common time of quantifiable concentration within a subject across all treatments (AUC0-t) and Area under the concentration time curve from time zero (pre-dose) extrapolated to infinite time (AUC0-inf). | The samples were collected for each period to 0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0 and 72.0 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mexico City | 03100 | Mexico |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D003872 | Dermatitis |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |