CTRI/2023/04/051381
Completed
Phase 1
An open label, Phase-1, parallel, dose-escalation, comparative pharmacokinetic,safety and tolerability study of Ursodiol injection 625mg/25ml (25mg/ml) at different dose levels (600 mg, 900 mg, 1800 mg & 3500 mg) with oral administration ofACTIGALL (Ursodiol) capsules 300 mg (Dose 900 mg) in healthy subjects under fedconditions.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shilpa Medicare Limited
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy human subjects between 18\-45 years of age (including both) and weight \= 50 Kg (BMI 18\.00\- 25\.00 kg/m²).
- •2\. Acceptable findings during registration and screening including, detailed medical history, full physical examination, medical examination, laboratory evaluations, 12\- lead ECG and Chest X\-Ray (postero\-anterior view).
- •3\. Values within Normal Ranges of Laboratory Parameters upon evaluation by the Investigator or Physician.
- •4\. Subjects able to communicate effectively.
- •5\. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
- •6\. Subject willing to abstain from all kinds of alcoholic beverages, smoking, and caffeine/xanthine containing foods or beverages from 96\.00 hours before admission till the last blood sample in study period.
- •7\. Male Subjects:
- •Subjects willing to follow approved birth
- •control methods (a double barrier method) for
- •the duration of the study as judged by the
Exclusion Criteria
- •1\. Volunteers having history of contraindication or hypersensitivity (e.g.,
- •anaphylaxis) to ursodeoxycholic acid or other related drugs, or related group of
- •2\. A history or presence of significant asthma, urticaria, or other allergic\-type
- •reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylacticlike
- •reactions to NSAIDs, seizures, diabetes, migraine, hypertension,
- •cardiovascular, pulmonary, neurological or psychiatric disease/disorder,
- •dermatological, endocrine, eye disorders, immunological, renal, hematopoietic,
- •gastrointestinal, ongoing infectious diseases, or any other significant
- •abnormality as evidenced by medical history and physical examination or
- •according to the opinion of the physician.
Outcomes
Primary Outcomes
Not specified
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