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This is a research study designed to evaluate the rate and extent of absorption of Naproxen from a novel Naproxen sodium tablet and Nalgesin naproxen sodium 275 mg.
The study has an open-label, randomized, two-way crossover design. 28 healthy participants will be included. Single-doses of 1 tablet of Naproxen sodium 275 mg and Nalgesin 275 mg will be given on separate treatment visits to healthy adult participants under fasting conditions. A crossover design is chosen in order to allow within-subject comparisons of treatments. To minimize the risk of carry-over effect, the washout period between the study drug administrations is set to 7 days. The study is open-label because the primary data collected are concentration measurements that cannot be expected to be affected by a participant's knowledge of the product administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence AB | Experimental | Participants will receive Treatment A (test product Naproxen sodium tablet, 1 x 275 mg) at dosing period 1 followed by Treatment B (reference product Nalgesin, 1 x 275 mg) dosing period 2. There is a wash-out period of 7 days between the two dosing periods. |
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| Treatment Sequence BA | Experimental | Participants will receive Treatment B (reference product Nalgesin, 1 x 275 mg) at dosing period 1 followed by Treatment A (test product Naproxen sodium tablet, 1 x 275 mg) at dosing period 2. There is a wash-out period of 7 days between the two dosing periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen sodium (test product) | Drug | Participants will be administered single doses of 275 mg Naproxen sodium (test product) tablet orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| The maximum observed plasma concentrations (Cmax) of Naproxen Sodium | The maximum observed plasma concentration (Cmax) | 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration |
| The area under the plasma concentration-vs.-time curves from start of Naproxen sodium administration until the time of the last measurable concentration (AUCt) | AUCt is defines as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration. | 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma concentration-vs.-time curve from the start of Naproxen sodium administration extrapolated to infinity (AUC∞) | AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the nicotine plasma concentration is negligible (infinity). | 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantin A. Zacharov, MD | LLC "Scientific and Research centre Eco-safety" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LLC "Scientific and Research centre Eco-safety" | Saint Petersburg | 196143 | Russia |
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| Label | URL |
|---|---|
| Synopsis to support result registration for a clinical study performed within the Russian federation. | View source |
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| Naproxen sodium (reference product) | Drug | Participants will be administered single doses of 275 mg Naproxen sodium (reference product - Nalgesin) tablet orally. |
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| The extrapolated part of AUC∞, AUCExtrap | 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration |
| The time at which maximum Naproxen sodium concentraton (Cmax) is observed (Tmax) | Tmax is defined as the time point at which the maximum nicotine concentration (Cmax) occurs | 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration |
| The terminal elimination rate constant (lambda-z) for Naproxen sodium | The rate at which the drug is removed from the body system. | 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration |
| The terminal elimination half-life (t1/2) of Naproxen sodium | The time taken for the Naproxen sodium plasma concentration to fall to half its original value. | 15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration |
| Number of participants with Adverse Events | An AE is any untoward from a medical standpoint event occurred in patient or subject of clinical study after the use of a medicinal product which may or may not have a causal relationship with its use. | Approximately 26 days |
| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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