Comparative Bioavailability Study of Human Chorionic Gonadotropin (hCG)-IBSA Versus a Marketed hCG Formulation
NCT03735030 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2021-03-11
Summary
In the present study, the rate and extent of hCG absorption will be compared between the two treatments in healthy women aged 20 to 45 years.
Conditions
Interventions
- DRUG
-
Human hCG 10'000 IU
A single dose of 10'000 IU of human hCG will be injected in 24 healthy subject volunteers.
- DRUG
-
Recombinant hCG 6'500 IU
A single dose of 6'500 IU recombinant hCG will be injected in 24 healthy subject volunteers.
Sponsors & Collaborators
-
IBSA Institut Biochimique SA
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-11-27
- Primary Completion
- 2019-08-02
- Completion
- 2019-08-02
Countries
- Switzerland
Study Locations
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