Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018093-55 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.
The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females. Drop-outs will not be replaced. The two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 days. In each study period, sixteen blood samples for pharmacokinetic analysis will be taken over 24 hours. Blood samples will be centrifuged and concentrations of paracetamol and phenylephrine in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tablet | Experimental | Paracetamol 500 mg/Phenylephrine 5 mg tablet |
|
| Sachet | Active Comparator | Paracetamol 1000 mg/Phenylephrine 10 mg sachet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol 500 mg/Phenylephrine 5 mg tablets | Drug | 2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic measurements | Pharmacokinetic measurements including:
| during 24 hours following drug administration |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Kruse, PhD | McNeil AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandon Clinical Trials Ltd. | Cork | Ireland |
Not provided
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D015508 | Nasal Obstruction |
| D006261 | Headache |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D009668 | Nose Diseases |
| D000402 | Airway Obstruction |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D010656 | Phenylephrine |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Paracetamol 1000 mg/Phenylephrine 10 mg sachet | Drug | 1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period |
|
|
| D012131 |
| Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |