An explorative, open label, randomized, single dose, pharmacokinetic study comparing two different CBD containing chewing gum formulations in healthy male volunteers - 170370-CS0291 Axim (Axim2017-02)

Axim Biotechnologies0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1. Subject is willing to give written informed consent.
•2. Subject is male and 18 to 45 years of age (inclusive) at Screening.
•3. Body mass index (BMI) is between 18 and 30 kg/m2 (inclusive) at Screening.
•4. Subject is in good health as judged by the Investigator and based on medical history, physical examination, vital sign measurements, ECG, and laboratory safety tests performed at Screening.
•5. Subject
•- must agree to use a condom with spermicide or abstain from sexual intercourse throughout the study (including washout intervals between treatment periods) until 90 days after the last dose of study drug in the last treatment period.
•- have been surgically sterilized prior to inclusion, AND
•- agree not to donate sperm during participation in the study and up to 3 months after follow up visit.

•1. Subject is mentally or legally incapacitated, has significant emotional problems at the time of Screening or is expected to get significant emotional problems during the conduct of the study or has a history of clinically significant psychiatric disorder within the last 5 years. Subjects who have had situational depression may be enrolled in the study at the discretion of the Investigator.
•2. Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases. Subjects with a history of cholecystectomy, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma may be enrolled in the study at the discretion of the investigator.
•3. Subject has a history of liver disease (exception: subjects with remote hepatitis A virus infection with full recovery can be included).
•4. Subject has a history of cancer (malignancy). Basal cell or stage I squamous cell carcinoma of the skin, which has been in remission for at least 5 years prior to administration of the study drug, may be allowed.
•5. Subject has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.

发起方

Axim Biotechnologies