Healthy volunteers help uncover Food-Drug interactions
NCT ID NCT07508501
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how taking ammoxetine tablets with or without food changes the drug levels in the body. Fourteen healthy adults participated in a two-period crossover design. The goal was to understand food's impact on drug absorption to guide future dosing recommendations.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
14 people
The number who actually took part.
- Started
-
Feb 2023
- Finished
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Apr 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age: 18-45 years (inclusive), both male and female subjects; 2. Body weight ≥ 45.0 kg (female) or 50.0 kg (male), with body mass index (BMI) between 19.0 kg/m² and 26.0 kg/m² (inclusive); 3. Results of medical history, vital signs, physical examination, and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, and other relevant tests) are normal or abnormal but without clinical significance; 4. Subjects and their partners must use effective non-hormonal contraceptive methods (e.g., condoms, non-hormonal intrauterine devices) from 2 weeks prior to screening until 6 months after the study completion, except for those who have already adopted permanent contraceptive measures (e.g., bilateral tubal ligation, vasectomy). Donation of sperm or eggs is also prohibited during this period; 5. Voluntarily sign the informed consent form and be willing to comply with the protocol to complete the study. Exclusion Criteria: 1. Subjects with a history of allergies (allergic to two or more types of drugs, foods, or pollen); 2. Subjects suffering from psychiatric disorders, hepatic or renal diseases, gastrointestinal diseases, neurological diseases, or other systemic diseases; 3. Subjects with clinically significant abnormalities confirmed by comprehensive examinations including medical history, physical examination, electrocardiogram, and chest X-ray; 4. Subjects with systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg during the screening period; 5. Subjects with orthostatic hypotension; 6. Subjects with corrected QT interval (QTc) ≥ 450 ms (male) or ≥ 470 ms (female), or a history of prolonged QTc interval; 7. Subjects with a history of smoking or alcohol abuse (consumption of 14 units of alcohol per week within the 4 weeks prior to screening: 1 unit = 285 mL beer, or 25 mL spirits, or 150 mL wine; daily smoking ≥ 5 cigarettes) or other substance or drug abuse within the past year; 8. Subjects who have donated or lost more than 400 mL of blood within the 8 weeks prior to screening; 9. Subjects who have participated in other clinical trials within the 3 months prior to screening; 10. Subjects who habitually consume excessive amounts of caffeinated beverages or foods within the 4 weeks prior to screening, such as coffee, tea, chocolate, cola, or Red Bull (daily caffeine intake not exceeding 6 units). 1 caffeine unit = 1 cup of coffee (177.4 mL) = 2 cans of cola (354.9 mL) = 1 cup of tea (354.9 mL) = 1/2 cup of energy drink = 85 g chocolate; 11. Subjects who have used medications that alter the activity of liver enzymes (Cytochrome P450 2C19 and Cytochrome P450 3A4) within the 4 weeks prior to screening, such as dexamethasone, ketoconazole, rifampicin, omeprazole, or grapefruit 12. Subjects who have used prescription drugs, over-the-counter medications (except for occasional use of acetaminophen and nasal sprays), herbal remedies, vitamins, or minerals within the 2 weeks prior to screening, or for whom the washout period of prior medications (based on the longest half-life) is less than 5 half-lives before screening; 13. Subjects using any psychiatric medications or psychoactive substances; 14. Pregnant or lactating women, or female subjects with a positive pregnancy test during the screening period; 15. Subjects who have already participated in this trial; 16. Subjects considered by the investigator to have any factors that make them unsuitable for participation in this trial.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Fourth Hospital of Hebei Medical University ,Hebei Tumor Hospital
Shijiazhuang, Hebei, 050035, China
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