Randomized, double-blind, placebo-controlled phase I dose escalation study of Dan Qi Tong Mai tablet in healthy volunteers

Table 1 Study design and subject allocation

Cohort	Single-dose study (once)								Multiple-dose study (twice daily for 14 days)
Cohort	1	2	3	4	5	6	7	8	9	10	11
Increase,%	Starting dose	200	100	100	67	60	50	33	–	–	–
Dose^a	90	270	540	1080	1800	2880	4320	5760	360	720	2160
Men	3	4	4	4	4	4	4	3	4	4	4
Women	3	4	4	4	4	4	4	3	4	4	4
Group allocation
Active ingredients	4	6	6	6	6	6	6	4	6	6	6
Placebo	2	2	2	2	2	2	2	2	2	2	2
Total	6	8	8	8	8	8	8	6	8	8	8

ISSN: 2662-7671